MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number AD3848

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this (b)(4) search for the subclass of cells damaged/leaking for lbh products, the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality ch.

Event Description

Event verbatim [preferred term] when she took wrap out of foil, it was all black like it had leaked/looked like one of the things exploded & covered the back of wrap/pc was not put altogether/pc wrap was all black like it had leaked [device leakage].Case narrative:this is a spontaneous report from a contactable consumer reported for herself.(b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) size l/xl, device lot number ad3848, expiration date oct2021, upc number: (b)(4) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Caller states she has used this type of product for approximately 2-3 years.She uses thermacare products all of time.Bought one yesterday, (b)(6) 2019, for her back and when she took the wrap out of the foil, it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.She had to get in the light better to see the print.Wrap was all black like the heat cells had been leaking and was not put altogether.On an unspecified date in (b)(6) 2019, there were 2 wraps in a pack and the packaging was sealed and intact.Consumer is requesting a refund.A sample of the product available to be returned.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to the product quality investigation results received on 21mar2019 for thermacare heatwrap: cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Further investigation is required.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment : the patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed., comment: the patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Manufacturer Narrative

Cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on (b)(6) 2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality ch.

Event Description

Event verbatim [preferred term] when she took wrap out of foil it was all black like it had leaked/looked like one of the things exploded&covered the back of wrap/pc was not put altogether/pc wrap was all black like it had leaked [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar event for two patients.This is the first of two reports, for herself.An 82-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) (size l/xl, device lot number ad3848, expiration date (b)(6) 2021, udi number (b)(4)) from an unspecified date in 2017 for an unspecified indication.The patient's medical history was not reported.Concomitant medications were reported as none.The patient stated she had used this type of product for approximately 2-3 years.She used thermacare products all of time.Bought one yesterday, (b)(6) 2019, for her back and when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.She had to get in the light better to see the print.Wrap was all black like the heat cells had been leaking and was not put altogether.On an unspecified date in mar2019, there were 2 wraps in a pack and the packaging was sealed and intact.A sample of the product available to be returned.She sent the affected thermacare lower back & hip wraps to pfizer.Action taken with the suspect product was continued.No therapeutic measures taken and no hospitalization was required as a result of the event.Clinical outcome of the event was unknown.According to the product quality investigation results received on 21mar2019 for thermacare heatwrap: cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on (b)(6) 2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Additional information has been requested and will be provided as it becomes available.Follow-up (01apr2019): new information received from a contactable consumer included: suspect product information and eu/ca device information was updated.Amendment: this follow-up report is being submitted to amend previously reported information: device medwatch information (evaluation codes) updated.Follow-up (21may2019): new information received from a contactable consumer includes: suspect product start date, action taken with suspect product, no concomitant medications, no therapeutic measures taken and no hospitalization required.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment the device malfunction from the returned sample has been confirmed. the patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot., comment: the device malfunction from the returned sample has been confirmed.The patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.

Manufacturer Narrative

Cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on (b)(6) 2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality ch.

Event Description

Event verbatim [preferred term] when she took wrap out of foil it was all black like it had leaked/looked like one of the things exploded&covered the back of wrap/pc was not put altogether/pc wrap was all black like it had leaked [device leakage].Case narrative:this is a spontaneous report from a contactable consumer reported for herself.An 82-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) size l/xl, device lot number ad3848, expiration date oct2021, upc number: 305733010037 from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Caller states she has used this type of product for approximately 2-3 years.She uses thermacare products all of time.Bought one yesterday, (b)(6) 2019, for her back and when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.She had to get in the light better to see the print.Wrap was all black like the heat cells had been leaking and was not put altogether.On an unspecified date in (b)(6) 2019, there were 2 wraps in a pack and the packaging was sealed and intact.Consumer is requesting a refund.A sample of the product available to be returned.She sent the affected thermacare lower back & hip wraps to pfizer.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to the product quality investigation results received on 21mar2019 for thermacare heatwrap: cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on (b)(6) 2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Further investigation is required.Additional information has been requested and will be provided as it becomes available.Follow-up (01apr2019): new information received from a contactable consumer included: suspect product information and eu/ca device information was updated.Company clinical evaluation comment: the patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.Comment: the patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Manufacturer Narrative

Cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality ch.

Event Description

Event verbatim [preferred term] when she took wrap out of foil it was all black like it had leaked/looked like one of the things exploded&covered the back of wrap/pc was not put altogether/pc wrap was all black like it had leaked [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar event for two patients.This is the first of two reports, for herself.An 82-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) size l/xl, device lot number ad3848, expiration date oct2021, udi number 305733010037, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient stated she had used this type of product for approximately 2-3 years.She used thermacare products all of time.Bought one yesterday, 14mar2019, for her back and when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.She had to get in the light better to see the print.Wrap was all black like the heat cells had been leaking and was not put altogether.On an unspecified date in mar2019, there were 2 wraps in a pack and the packaging was sealed and intact.A sample of the product available to be returned.She sent the affected thermacare lower back & hip wraps to pfizer.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to the product quality investigation results received on 21mar2019 for thermacare heatwrap: cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Further investigation is required.Additional information has been requested and will be provided as it becomes available.Follow-up (01apr2019): new information received from a contactable consumer included: suspect product information and eu/ca device information was updated.Amendment: this follow-up report is being submitted to amend previously reported information: device medwatch information (evaluation codes) updated.Company clinical evaluation comment the patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed., comment: the patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

Event Description

When she took wrap out of foil it was all black like it had leaked/looked like one of the things exploded & covered the back of wrap/pc was not put altogether/pc wrap was all black like it had leaked/ha [device leakage].Case narrative:this is a spontaneous report from a contactable consumer reported for herself.An 82-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) (size l/xl, device lot number: ad3848, expiration date: oct2021, udi number: (b)(4) from an unspecified date in 2017 for heat for back pain.The patient's medical history was not reported.Concomitant medications were reported as none.The patient stated she had used this type of product for approximately 2-3 years.She used thermacare products all of time.Bought one yesterday, on (b)(6) 2019, for her back and when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.She had to get in the light better to see the print.Wrap was all black like the heat cells had been leaking and was not put altogether.On an unspecified date on (b)(6) 2019, there were 2 wraps in a pack and the packaging was sealed and intact.A sample of the product available to be returned.She sent the affected thermacare lower back & hip wraps to pfizer.The patient further also mentioned that she had a complaint on thermacare back pain therapy heatwraps.She had no problem except for a month ago had leaked.On an unspecified date, the patient stated that she went to return thermacare that was the wrong size.Did not have l or xl so they called another one and they had five but were being recalled.Action taken with the suspect product was continued.No therapeutic measures taken and no hospitalization was required as a result of the event.Clinical outcome of the event was resolved.According to the product quality investigation results received on 21mar2019 for thermacare heatwrap: cell damage/leakage severity rank: s 3.Batch: ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.According to the product quality investigation results received on 19aug2019, rsnbly suggest device malfunc? yes.Severity of harm: s3.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour, effective 23apr2019, version 5.0.Refer to attachment notification to safety pr#.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: site notification date: 01jun2016 through 30jun2019/manufacturing site: pfizer albany/complaint class: product appearance /complaint sub class: heat cells damaged/leaking - cells damaged/leaking.The citi customizable search returned a total of 65 complaints for lower back/hip (lbh) 8hr products during this time period for the class/subclass.Of the 65 complaints; 8 of the 65 records were identified as having a manufacturing related root cause of the wrap having cells/damaged/ leaking defects.Summary of the confirmed complaints as follows: pqc #-ik (pr-#) identified the root cause as method/procedure document unclear/lacking detail.B line/m line prevent defective wraps from comingling with good quality wraps when in dry run mode mwi sop-# didn't provide clear instructions to guide the production colleague so that the off quality portion of the web was marked and walked down to ensure it was removed from the process before disabling dry run by ensuring the off quality product was removed before disabling the "dry-run" feature.Work order number: (b)(4) was executed to establish pressure and temperature parameters to run the auto splices in the automatic mode.There are no corrective actions required for this event because this investigation is related to a returned wrap from the market.A preventive action was identified to avoid the use of the red tape when a splice is made and the equipment is run in automatic mode.On (b)(6) 2018 work order number: (b)(4) was executed to establish pressure and temperature parameters to run the auto splices in the automatic mode.No additional preventive action is required at this time because pr# has been initiated on 12mar2018 to revise sop-77453, b line/m line prevent defective wraps from comingling with good quality wraps when in dry run mode mwi,version 2.0, effective date 03 oct 2016 to prevent defective wraps from comingling with good quality wraps when in dry run mode.Pqc#: us (pr-3481692) determined the root cause to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Closed on 29jul2019.Commitment pr-# was issued to create the brine pumps pm.It will include an inspection and cleaning of the brine pumps, lines and nozzles routinely.Closed on 29jul2019.Pqc #-us (pr-#) the most probable root cause of this event is method/document doesn't exist.The re-taping of the web that created a gathered up (bunched up) web after the splice broke out (came apart) of the web on 17may2018 misaligned the die registration optics when it passed between the optics.This splice should be assisted (move away) by the manufacturing technician to prevent physical contact with the registration optics.There is no procedure in place that provides instructions to manage this kind of splice.This is the most probable cause of this incident.Commitment pr-# was issued to re-classified the b and m line die cutter infeed conveyor vacuum centerline from non-critical to critical.The set points should be defined.If the risk assessment asmt-24946 "centerline risk assessment" is impacted with this change it should be updated.Commitment pr-# was issued to create a procedure to manage the splice broke outs (came apart) on carrier web (uws0) where the re-taping of the web created to resume production should be walked down to ensure it doesn't travel through the registration optics and change its position.Commitment pr-# was issued to install a camera inspection system to detect and reject defective product from b-line including wraps with cut cells.Cancelled.Commitment pr-# was issued to update rpt-38832" hazard analysis, thermacare heat wrap product: 8 and 12 hour", version 5.0.The new version will include the potential cause id and the potential cause-failure mechanism description related to the die registration optics misaligned scenario.Cancelled.Commitment pr-# was issued to update rpt-39239 "process failure mode and effect analysis", v.6.0 effective date 04feb2019.The new version will include the cause id and the potential cause-failure mechanism related to the die registration optics misaligned scenario.Cancelled.Commitment pr-# was issued to update sop-99871 "b/m line converting rotary die cutter registration (operating window) set-up mwi", v.2.0 effective date 01-mar-2019.The change will include instructions to open the cull station during the die cutter registration adjustments.Cancelled.Pqc #-us (pr -#) based on the outcome of the interviews, evaluation of downtime, shift transition report and shift maintenance report the cut wraps could be produced by the combination of the die set up and the excessive wear of the nip roll.During the die troubleshooting to avoid the die popping, it was adjusted within the die registration operating window but not in the center.This fact and the excessive wear of the nip roll that caused a web mistracking could produce the conditions to manufacture the defective wraps of this incident.There is no sop to perform the die adjustment or re-calibration and how to perform the troubleshooting under the die popping situation if the web is not well controlled (slipping) the registration optics will be erratic to determine the web cutting position and the die will popping continuously.An sop (sop-88124) and pm (preventive maintenance) were put in place for periodic verification of nip roll in b-line.Commitment#: 1943236 was issued to create a procedure to adjust the die and re-calibrate it and how to perform the troubleshooting during the die popping events.- closed on 01sep2017.Commitment#: 1943296 was issued to activate the hmi tool that shows the current die position using a controlled system.- closed on 07feb2018.Commitment#: 1943303 was issued to create a pm to inspect the wear of the nip roll in m-line.Closed on 26oct2017.Pqc #-gs ( pr - #) there was one wrap attribute defect recorded for the batch; heat seal integrity.Per spec-2345, effective date: 28apr2015, lower back and hip this is a critical defect.The production line was shut down.The production operators changed the forming vacuum filters and the hold down filters to correct the stray chemistry that was interfering with the proper sealing of the individual cells.The forming vacuum draws the polyethylene sheet into the forming cells, which are in the forming plates, to create a cavity for the chemistry.Without this cavity the chemistry will fall outside of the cell area interfering with cell sealing.When the forming vacuum filters begin to clog the vacuum is reduced and the cells are not properly formed.The hold down vacuum filters hold the forming plates down to stabilize the chemistry dosing process.The operators changed hpm forming and hold down filters, rotated cart and cleaned platen screens, cleaned seal roll.Scrapped the product in the accumulator and entire line.There are no additional corrective actions documented in the shift transition report, qw or work order.There is no evidence that this was a prolonged event.There is no corrective and preventive action documented in the shift transition report, qw or work order.There is no evidence that this was a prolonged event.Pqc # (pr - #) the most probable root cause of this event is in the equipment category, mechanical failure.A brine hose connection to a brine nozzle most probably became loose.This caused brine to pool on the top of the brine nozzle plate and allowed brine to spill onto the bottom sheet.This prevented the top and bottom sheets from sealing and created the defect.Method is ruled out as the root cause.There was no finding centered on a process.Materials are ruled out as the root cause.Qc lab analysts verify the materials are within specification before releasing the material to production.There is no corrective and preventive action documented in the shift transition report, qw or work order.There is no evidence that this was a prolonged event.Pqc # (pr - #) the most probable root cause of this event is in the equipment category, mechanical failure.Based on the damage found on the returned wraps, information gathered during interviews and the evidence from investigation (b)(4), the die cutter infeed conveyor slipped on the drive roll.Method is ruled out as the root cause.There was no finding centered on a process.The operators were following normal operating and troubleshooting processes which do not control the slippage of conveyor belts.There are no corrective actions identified for this event.Preventive action was accomplished with the completion of wo's # (belt replacement) and # (nip roll replacement).Commitment# was initiated under pr # to revise the b-line die cutter pm to include specific instructions for checking and retensioning the die cutter station infeed belt.(name), due date on (b)(6) 2017 - closed on 20mar2017.Pqc #- gc (pr - #) the most probable root cause of this event is in the equipment category, mechanical failure.Die cutter infeed conveyor slipped on the drive roll.Method is ruled out as the root cause.There was no finding centered on a process.The operators were following normal operating and troubleshooting processes which do not control the slippage of conveyor belts.There are no corrective actions identified for this event.Preventive action was accomplished with the completion of wo's#: (b)(4) (belt replacement) and #: (b)(4) (nip roll replacement).Commitment# pr 1669729 was initiated to revise the b-line die cutter pm to include specific instructions for checking and re-tensioning the die cutter station infeed belt.(name), due date on (b)(6) 2017 - closed on 20mar2017.Commitment# pr 1669734 was initiated to create a pm for the inspection of the nip rolls.(name), due date (b)(6) 2017- closed on 19apr2017.Based on a citi search was conducted for the subclass heat cells damaged/leaking - cell damaged/leaking for lbh.Refer to attachment trending graph lbh for heat cells damaged/leaking - cell damaged/leaking june 2016 to june 2019.Follow-up (01apr2019): new information received from a contactable consumer included: suspect product information and eu/ca device information was updated.Amendment: this follow-up report is being submitted to amend previously reported information: device medwatch information (evaluation codes) updated.Follow-up (21may2019): new information received from a contactable consumer includes: suspect product start date, action taken with suspect product, no concomitant medications, no therapeutic measures taken and no hospitalization required.Follow-up attempts are completed.No further information is expected.Follow up (24jun2019): new information received from a contactable consumer includes event details.No follow up attempts are possible.No further information is expected.Follow-up (12aug2019): this is a follow-up report combining information from duplicate reports 2019204011 and 2019121839.The current and all subsequent information will be reported under manufacturer report number 2019121839.New information includes patient comment.No follow-up attempts are possible.No further information is expected.Follow-up (19aug2019): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: the device malfunction from the returned sample has been confirmed.The patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot., comment: the device malfunction from the returned sample has been confirmed.The patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.

Manufacturer Narrative

Cell damage/leakage severity rank: s 3.Batch: ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality ch.

Manufacturer Narrative

Cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality ch.

Event Description

Event verbatim [preferred term] when she took wrap out of foil it was all black like it had leaked/looked like one of the things exploded&covered the back of wrap/pc was not put altogether/pc wrap was all black like it had leaked [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar event for two patients.This is the first of two reports, for herself.An 82-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) (size l/xl, device lot number ad3848, expiration date oct2021, udi number (b)(4)) from an unspecified date in 2017 for heat for back pain.The patient's medical history was not reported.Concomitant medications were reported as none.The patient stated she had used this type of product for approximately 2-3 years.She used thermacare products all of time.Bought one yesterday, 14mar2019, for her back and when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.She had to get in the light better to see the print.Wrap was all black like the heat cells had been leaking and was not put altogether.On an unspecified date in mar2019, there were 2 wraps in a pack and the packaging was sealed and intact.A sample of the product available to be returned.She sent the affected thermacare lower back & hip wraps to pfizer.The patient further also mentioned that she had a complaint on thermacare back pain therapy heatwraps.Action taken with the suspect product was continued.No therapeutic measures taken and no hospitalization was required as a result of the event.Clinical outcome of the event was resolved.According to the product quality investigation results received on 21mar2019 for thermacare heatwrap: cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Follow-up (01apr2019): new information received from a contactable consumer included: suspect product information and eu/ca device information was updated.Amendment: this follow-up report is being submitted to amend previously reported information: device medwatch information (evaluation codes) updated.Follow-up (21may2019): new information received from a contactable consumer includes: suspect product start date, action taken with suspect product, no concomitant medications, no therapeutic measures taken and no hospitalization required.Follow-up attempts are completed.No further information is expected.Follow up (24jun2019): new information received from a contactable consumer includes event details.No follow up attempts are possible.No further information is expected.Company clinical evaluation comment.The device malfunction from the returned sample has been confirmed.The patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot., comment: the device malfunction from the returned sample has been confirmed.The patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.

Event Description

Event verbatim [preferred term] when she took wrap out of foil it was all black like it had leaked/looked like one of the things exploded&covered the back of wrap/pc was not put altogether/pc wrap was all black like it had leaked/ha [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer reported similar event for two patients.This is the first of two reports, for herself.An 82-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) (size l/xl, device lot number ad3848, expiration date oct2021, udi number 305733010037) from an unspecified date in 2017 for heat for back pain.The patient's medical history was not reported.Concomitant medications were reported as none.The patient stated she had used this type of product for approximately 2-3 years.She used thermacare products all of time.Bought one yesterday, 14mar2019, for her back and when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.She had to get in the light better to see the print.Wrap was all black like the heat cells had been leaking and was not put altogether.On an unspecified date in mar2019, there were 2 wraps in a pack and the packaging was sealed and intact.A sample of the product available to be returned.She sent the affected thermacare lower back & hip wraps to pfizer.The patient further also mentioned that she had a complaint on thermacare back pain therapy heatwraps.On an unspecified date, the patient stated that she went to return thermacare that was the wrong size.Did not have l or xl so they called another one and they had five but were being recalled.Action taken with the suspect product was continued.No therapeutic measures taken and no hospitalization was required as a result of the event.Clinical outcome of the event was resolved.According to the product quality investigation results received on 21mar2019 for thermacare heatwrap: cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Follow-up (01apr2019): new information received from a contactable consumer included: suspect product information and eu/ca device information was updated.Amendment: this follow-up report is being submitted to amend previously reported information: device medwatch information (evaluation codes) updated.Follow-up (21may2019): new information received from a contactable consumer includes: suspect product start date, action taken with suspect product, no concomitant medications, no therapeutic measures taken and no hospitalization required.Follow-up attempts are completed.No further information is expected.Follow up (24jun2019): new information received from a contactable consumer includes event details.No follow up attempts are possible.No further information is expected.Follow-up (12aug2019): this is a follow-up report combining information from duplicate reports (b)(4) and (b)(4).The current and all subsequent information will be reported under manufacturer report number (b)(4).New information includes patient comment.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment: the device malfunction from the returned sample has been confirmed.The patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot., comment: the device malfunction from the returned sample has been confirmed.The patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.

Manufacturer Narrative

Cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, 10 pouches and the 10 wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All 10 wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality ch.

Event Description

Event verbatim [preferred term] when she took wrap out of foil it was all black like it had leaked/like one of the things exploded&covered the back of wrap/no problem except for a month ago had leaked [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.An 82-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) (size l/xl, device lot number ad3848, expiration date oct2021, udi number (b)(4)) from an unspecified date in 2017 for heat for back pain.The patient's medical history was not reported.Concomitant medications were reported as none.The patient stated she had used this type of product for approximately 2-3 years.She used thermacare products all of time.Bought one yesterday, (b)(6)2019, for her back and when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.She had to get in the light better to see the print.Wrap was all black like the heat cells had been leaking and was not put altogether.On an unspecified date in (b)(6)2019, there were 2 wraps in a pack and the packaging was sealed and intact.A sample of the product available to be returned.She sent the affected thermacare lower back & hip wraps to pfizer.The patient further also mentioned that she had a complaint on thermacare back pain therapy heatwraps.She had had no problem except for a month before had leaked.On an unspecified date, the patient stated that she went to return thermacare that was the wrong size.Did not have l or xl so they called another one and they had five but were being recalled.Action taken with the suspect product was continued.No therapeutic measures taken and no hospitalization was required as a result of the event.Clinical outcome of the event was resolved in 2019.According to the product quality investigation results received on (b)(6)2019 for thermacare heatwrap: cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, (b)(4) pouches and the (b)(4) wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All (b)(4) wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on (b)(4)2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.According to the product quality investigation results received on (b)(4)2019, rsnbly suggest device malfunc?: yes.Severity of harm: s3.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: site notification date: 01jun2016 through 30jun2019/manufacturing site: pfizer albany/complaint class: product appearance /complaint sub class: heat cells damaged/leaking - cells damaged/leaking.The citi customizable search returned a total of 65 complaints for lower back/hip (lbh) 8hr products during this time period for the class/subclass.Of the (b)(4) complaints; (b)(4) of the(b)(4) records were identified as having a manufacturing related root cause of the wrap having cells/damaged/ leaking defects.Summary of the confirmed complaints as follows: pqc #-ik (pr-#) identified the root cause as method/procedure document unclear/lacking detail.B line/m line prevent defective wraps from comingling with good quality wraps when in dry run mode mwi sop-# didn't provide clear instructions to guide the production colleague so that the off quality portion of the web was marked and walked down to ensure it was removed from the process before disabling dry run by ensuring the off quality product was removed before disabling the "dry-run" feature.Work order number: (b)(4) was executed to establish pressure and temperature parameters to run the auto splices in the automatic mode.There are no corrective actions required for this event because this investigation is related to a returned wrap from the market.A preventive action was identified to avoid the use of the red tape when a splice is made and the equipment is run in automatic mode.On (b)(6)2018 work order number: 4801144 was executed to establish pressure and temperature parameters to run the auto splices in the automatic mode.No additional preventive action is required at this time because pr# #has been initiated on (b)(6)2018 to revise sop-77453, b line/m line prevent defective wraps from comingling with good quality wraps when in dry run mode mwi,version 2.0, effective date 03 oct 2016 to prevent defective wraps from comingling with good quality wraps when in dry run mode.Pqc #-us (pr-3481692) determined the root cause to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Closed on (b)(6)2019.Commitment pr-# was issued to create the brine pumps pm.It will include an inspection and cleaning of the brine pumps, lines and nozzles routinely.Closed on (b)(6)2019.Pqc #-us (pr-#) the most probable root cause of this event is method/document doesn't exist.The re-taping of the web that created a gathered up (bunched up) web after the splice broke out (came apart) of the web on 17may2018 misaligned the die registration optics when it passed between the optics.This splice should be assisted (move away) by the manufacturing technician to prevent physical contact with the registration optics.There is no procedure in place that provides instructions to manage this kind of splice.This is the most probable cause of this incident.Commitment pr-# was issued to re-classified the b and m line die cutter infeed conveyor vacuum centerline from non-critical to critical.The set points should be defined.If the risk assessment asmt-24946 "centerline risk assessment" is impacted with this change it should be updated.Commitment pr-# was issued to create a procedure to manage the splice broke outs (came apart) on carrier web (uws0) where the re-taping of the web created to resume production should be walked down to ensure it doesn't travel through the registration optics and change its position.Commitment pr-# was issued to install a camera inspection system to detect and reject defective product from b-line including wraps with cut cells.Cancelled.Commitment pr-# was issued to update rpt-38832"hazard analysis, thermacare heat wrap product: 8 and 12 hour", version 5.0.The new version will include the potential cause id and the potential cause-failure mechanism description related to the die registration optics misaligned scenario.Cancelled.Commitment pr-# was issued to update rpt-39239 "process failure mode and effect analysis", v.6.0 effective date 04feb2019.The new version will include the cause id and the potential cause-failure mechanism related to the die registration optics misaligned scenario.Cancelled.Commitment pr-# was issued to update sop-99871 "b/m line converting rotary die cutter registration (operating window) set-up mwi", v.2.0 effective date 01-mar-2019.The change will include instructions to open the cull station during the die cutter registration adjustments.Cancelled.Pqc #-us (pr -#) based on the outcome of the interviews, evaluation of downtime, shift transition report and shift maintenance report the cut wraps could be produced by the combination of the die set up and the excessive wear of the nip roll.During the die troubleshooting to avoid the die popping, it was adjusted within the die registration operating window but not in the center.This fact and the excessive wear of the nip roll that caused a web mistracking could produce the conditions to manufacture the defective wraps of this incident.There is no sop to perform the die adjustment or re-calibration and how to perform the troubleshooting under the die popping situation if the web is not well controlled (slipping) the registration optics will be erratic to determine the web cutting position and the die will popping continuously.An sop (sop-88124) and pm (preventive maintenance) were put in place for periodic verification of nip roll in b-line.Commitment # 1943236 was issued to create a procedure to adjust the die and re-calibrate it and how to perform the troubleshooting during the die popping events.- closed on (b)(6)2017.Commitment # 1943296 was issued to activate the hmi tool that shows the current die position using a controlled system.- closed on (b)(6)2018.Commitment # 1943303 was issued to create a pm to inspect the wear of the nip roll in m-line.Closed on 26oct2017.Pqc #-gs ( pr - #) there was one wrap attribute defect recorded for the batch; heat seal integrity.Per spec-2345, effective date: 28apr2015, lower back and hip this is a critical defect.The production line was shut down.The production operators changed the forming vacuum filters and the hold down filters to correct the stray chemistry that was interfering with the proper sealing of the individual cells.The forming vacuum draws the polyethylene sheet into the forming cells, which are in the forming plates, to create a cavity for the chemistry.Without this cavity the chemistry will fall outside of the cell area interfering with cell sealing.When the forming vacuum filters begin to clog the vacuum is reduced and the cells are not properly formed.The hold down vacuum filters hold the forming plates down to stabilize the chemistry dosing process.The operators changed hpm forming and hold down filters, rotated cart and cleaned platen screens, cleaned seal roll.Scrapped the product in the accumulator and entire line.There are no additional corrective actions documented in the shift transition report, qw or work order.There is no evidence that this was a prolonged event.There is no corrective and preventive action documented in the shift transition report, qw or work order.There is no evidence that this was a prolonged event.Pqc # (pr - #) the most probable root cause of this event is in the equipment category, mechanical failure.A brine hose connection to a brine nozzle most probably became loose.This caused brine to pool on the top of the brine nozzle plate and allowed brine to spill onto the bottom sheet.This prevented the top and bottom sheets from sealing and created the defect.Method is ruled out as the root cause.There was no finding centered on a process.Materials are ruled out as the root cause.Qc lab analysts verify the materials are within specification before releasing the material to production.There is no corrective and preventive action documented in the shift transition report, qw or work order.There is no evidence that this was a prolonged event.Pqc # (pr - #) the most probable root cause of this event is in the equipment category, mechanical failure.Based on the damage found on the returned wraps, information gathered during interviews and the evidence from investigation 1623759, the die cutter infeed conveyor slipped on the drive roll.Method is ruled out as the root cause.There was no finding centered on a process.The operators were following normal operating and troubleshooting processes which do not control the slippage of conveyor belts.There are no corrective actions identified for this event.Preventive action was accomplished with the completion of wo's # (belt replacement) and # (nip roll replacement).Commitment # was initiated under pr # to revise the b-line die cutter pm to include specific instructions for checking and retensioning the die cutter station infeed belt.(name), due date 23mar2017 - closed on 20mar2017.Pqc #- gc (pr - #) the most probable root cause of this event is in the equipment category, mechanical failure.Die cutter infeed conveyor slipped on the drive roll.Method is ruled out as the root cause.There was no finding centered on a process.The operators were following normal operating and troubleshooting processes which do not control the slippage of conveyor belts.There are no corrective actions identified for this event.Follow-up (01apr2019): new information received from a contactable consumer included: suspect product information and eu/ca device information was updated.Amendment: this follow-up report is being submitted to amend previously reported information: device medwatch information (evaluation codes) updated.Follow-up (21may2019): new information received from a contactable consumer includes: suspect product start date, action taken with suspect product, no concomitant medications, no therapeutic measures taken and no hospitalization required.Follow-up attempts are completed.No further information is expected.Follow up (24jun2019): new information received from a contactable consumer includes event details.No follow up attempts are possible.No further information is expected.Follow-up (12aug2019): this is a follow-up report combining information from duplicate reports 2019204011 and 2019121839.The current and all subsequent information will be reported under manufacturer report number 2019121839.New information includes patient comment.No follow-up attempts are possible.No further information is expected.Follow-up (19aug2019): new information received from a product quality complaint group included: investigation results.Follow-up (30aug2019): new information received from a product quality complaint group included: updated investigation results.Company clinical evaluation comment: the device malfunction from the returned sample has been confirmed.The patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: the device malfunction from the returned sample has been confirmed.The patient reported that when she took the wrap out of the foil it was all black like it had leaked.It looked like one of the things exploded and covered the back of the wrap.The single event device leakage is medically assessed as associated with the use of the device.No other adverse event such as burn was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Cell damage/leakage severity rank: s 3.Batch ad3848 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain samples included five cartons, (b)(4) pouches and the (b)(4) wraps inside.Inspection shows no obvious defects to cartons, pouches or wraps.All (b)(4) wraps have sealed cell packs, no damage or leaking cells.Retain sample inspection form documented the retain evaluation performed on 20mar2019.An evaluation of the complaint history confirms this is the first complaint for the sub class cells damaged/leaking received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The root cause was determined to be equipment / mechanical failure.The returned wrap shows two cells were not totally sealed and the chemistry-brine mix was out of the cells.There was no stray chemistry out of the wrap.Examination of the unsealed areas found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges were not properly sealed because of the presence of brine.Commitment pr-# was completed to create the brine pumps preventative maintenance.It includes an inspection and cleaning of the brine pumps, lines and nozzles routinely.Based on this pcom search for the subclass of cells damaged/leaking for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cell damaged/leaking for lbh products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality ch.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8461863
• MDR Text Key: 147172787
• Report Number: 1066015-2019-00081
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/15/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Lot Number: AD3848
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/12/2019; 05/16/2019; 06/03/2019; 07/09/2019; 08/23/2019; 09/04/2019; 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR