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| Lot Number S97473 |
| Device Problem
Temperature Problem (3022)
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| Patient Problems
Skin Discoloration (2074); Burn, Thermal (2530)
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| Event Date 03/01/2019 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] he received burns/blisters/skin is discolored where the 3 rocks or heat cells were [burns second degree] , the wraps were recalled because of the cell temperatures [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for her boyfriend.A (b)(6)-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number s97473, expiration date 03/31/2020, applied to lower back as needed from 2016 to 2019 for back pain.Medical history included he was injured and couldn't walk.Concomitant medications were none.The patient was injured and used the wraps.He received burns/blisters on back.He used the back pain therapy wraps.The wraps were recalled because of the cell temperatures.He had pictures on his phone of his back.He went to the gas station and couldn't walk.He was having back issues and used the wrap.He still had issues with his back.He got epidural shots and he always used the wraps.Reporter did not know if he received an injection before or after he used the wrap.He still had marks on his back.The skin was discolored where the 3 rocks or heat cells were.He was burned sometime in (b)(6) 2019.He stopped using the wraps in (b)(6) 2019.He had an mri for his back.The patient was currently under the care of a physician for any medical condition.He classified his skin tone as colour.He did not have sensitive skin or abnormal skin conditions.The red box was purchased.He used thermacare maybe a couple of hours per day.He previously used thermacare and he did not experience the same problem.He had not previously used other heat products for pain relief.He attached the adhesive to body.He did not engage in exercise while using the product.He checked his skin under the product while wearing thermacare after he was burned.The burn/blister had healed.He had 3 marks on back from the heat cells.The action taken in response to the events of the product was permanently discontinued.The outcome of the events was resolved.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of burns second degree and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of burns second degree and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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Lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi customizable search, there is not a trend identified for the subclass of adverse events/serious/unknown.The device history record for this lot has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving an adverse event/serious/unknown.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer alleges the heat wrap caused a burn while using the heatwrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include inprocess testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of dhr, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures (37.6°c - 41.9°c) per spec-23451, effective date: 28nov2016.Investigations for the lot (lir-1842197 and er- 1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotte.
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Event Description
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He received burns/blisters/skin is discolored where the 3 rocks or heat cells were [burns second degree].The wraps were recalled because of the cell temperatures [device issue].Case description: this is a spontaneous report from a contactable consumer reported for her boyfriend.A 37-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number s97473, expiration date 31mar2020, applied to lower back as needed from 2016 to 2019 for back pain.Medical history included he was injured and couldn't walk.Concomitant medications were none.The patient was injured and used the wraps.He received burns/blisters on back.He used the back pain therapy wraps.The wraps were recalled because of the cell temperatures.He had pictures on his phone of his back.He went to the gas station and couldn't walk.He was having back issues and used the wrap.He still had issues with his back.He got epidural shots and he always used the wraps.Reporter did not know if he received an injection before or after he used the wrap.He still had marks on his back.The skin was discolored where the 3 rocks or heat cells were.He was burned sometime in (b)(6) 2019.The reporter confirmed the patient was burned by using the heatwraps correctly.Hospital admission was involved for the events.The reporter denied the patient received any treatment for the events.He stopped using the wraps in (b)(6) or (b)(6) 2019.The action taken in response to the events of the product was permanently discontinued.He had an mri for his back.The patient was currently under the care of a physician for any medical condition.He classified his skin tone as "colour".He did not have sensitive skin or abnormal skin conditions.The red box was purchased.He used thermacare maybe a couple of hours per day.He previously used thermacare heatwraps and he did not experience the same problem.He had not previously used other heat products for pain relief.He attached the adhesive to body.He did not engage in exercise while using the product.He checked his skin under the product while wearing thermacare after he was burned.The burn/blister had healed on an unspecified date.He had 3 marks on back from the heat cells.He still has the mark (burns) on his back from them as of the report on (b)(6) 2019.He did contact his doctor to let him know.The outcome of the events was resolved with sequel.According to product quality complaint group: lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi customizable search, there is not a trend identified for the subclass of adverse events/serious/unknown.The device history record for this lot has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving an adverse event/serious/unknown.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer alleges the heat wrap caused a burn while using the heatwrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.No quality issues were identified upon this review of dhr, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures (37.6°c - 41.9°c) per spec-23451, effective date: 28nov2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, (b)(4), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019 and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.Upon follow-up, product quality complaints provided the severity of harm as s3 (injury, which could result in the need for medical treatment and hospitalization).It was confirmed that severity of harm is assessed as s3 for burn/blisters as the patient developed burn injuries with product use.Follow-up(30jul2019): new information received from a product quality complaint group included: investigation results.Follow-up (04aug2019): new information received from product quality complaint group included: severity of harm rating (s3).Follow-up (08oct2019): new information from a contactable consumer includes: updated seriousness (hospitalization), treatment information (none received), event details (burned by them using them correctly), and outcome ("still has the mark (burns) on his back from them;" outcome updated to recovered with sequel).Follow-up (27aug2019): new information received from a product quality complaint group included: summary of investigation and conclusion, sterile: no, additional citi search with different date (02aug2017 through 02aug2019), sample not available, reserve sample evaluation, lot trend assessment, reasonably suggest device malfunction, severity of harm: n/a, and other investigation findings.Follow-up attempts are completed.No further information in expected.Follow-up (08nov2019): new information received from a product quality complaint group included: it was confirmed that severity of harm is assessed as s3 for burn/blisters as the patient developed burn injuries with product use.Company clinical evaluation comment: based on the information provided, the events of burns second degree and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The above referenced lot number s97473 was recalled on 26apr2019.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall due to out of specification results for high cell temperature that could result potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap applied area.This lot was distributed in the united states and puerto rico with expiry dates of 3/31/2020.
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Manufacturer Narrative
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Lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.An evaluation of the complaint history confirms that this is the 14th complaint for the sub class adverse event safety request for investigation received at the (site name) site requiring an evaluation for this batch.The previous complaints evaluated were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: responsible site notification date: 26jul2017through 29jul2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 545 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were identified as having a manufacturing related root cause of for adverse event safety request for investigation.The subclass shows an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.Seven complaints were related to batch s97473.None were confirmed to have a manufacturing p.
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Event Description
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He received burns/blisters/skin is discolored where the 3 rocks or heat cells were [burns second degree].The wraps were recalled because of the cell temperatures [device issue].Case description: this is a spontaneous report from a contactable consumer reported for her boyfriend.A 37-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number s97473, expiration date 31mar2020, applied to lower back as needed from 2016 to 2019 for back pain.Medical history included he was injured and couldn't walk.Concomitant medications were none.The patient was injured and used the wraps.He received burns/blisters on back.He used the back pain therapy wraps.The wraps were recalled because of the cell temperatures.He had pictures on his phone of his back.He went to the gas station and couldn't walk.He was having back issues and used the wrap.He still had issues with his back.He got epidural shots and he always used the wraps.Reporter did not know if he received an injection before or after he used the wrap.He still had marks on his back.The skin was discolored where the 3 rocks or heat cells were.He was burned sometime in mar2019.The reporter confirmed the patient was burned by using the heatwraps correctly.Hospital admission was involved for the events.The reporter denied the patient received any treatment for the events.He stopped using the wraps in (b)(6) or (b)(6) 2019.The action taken in response to the events of the product was permanently discontinued.He had an mri for his back.The patient was currently under the care of a physician for any medical condition.He classified his skin tone as "colour".He did not have sensitive skin or abnormal skin conditions.The red box was purchased.He used thermacare maybe a couple of hours per day.He previously used thermacare and he did not experience the same problem.He had not previously used other heat products for pain relief.He attached the adhesive to body.He did not engage in exercise while using the product.He checked his skin under the product while wearing thermacare after he was burned.The burn/blister had healed on an unspecified date.He had 3 marks on back from the heat cells.He still has the mark (burns) on his back from them as of the report on (b)(6) 2019.He did contact his doctor to let him know.The outcome of the events was resolved with sequel.According to product quality complaint group: lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.An evaluation of the complaint history confirms that this is the 14th complaint for the sub class adverse event safety request for investigation received at the (site name) site requiring an evaluation for this batch.The previous complaints evaluated were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: responsible site notification date: 26jul2017through 29jul2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 545 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were identified as having a manufacturing related root cause of for adverse event safety request for investigation.The subclass shows an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.Seven complaints were related to batch s97473.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The remaining recall batches were not reported.Based on this citi customizable search, the trending chart shows an increase in adverse events (aes) for april2019 and may2019 for the subclass of adverse events safety request for investigation for lbh products.Refer to the attached trend chart for lbh adverse event jul2017 to jul2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.These complaints are classified as open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.There is no further action required.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: responsible site notification date: 02aug2017 through 02aug2019/manufacturing site: pfizer albany/complaint class: external cause investigation complaint sub class: adverse event/serious/unknown.The citi customizable search returned a total of 20 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were identified as having a manufacturing related root cause of for adverse event/serious/unknown.Based on this citi customizable search, there is not a trend identified for the subclass of adverse events/serious/unknown.There is no further action required.The device history record for this lot has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving an adverse event/serious/unknown.Review of the device history record (dhr) for this lot concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this lot indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the lot shows all wraps met the required wrap batch average temperatures (37.6°c to 41.6°c) per spec 23451, effective: 28-nov-2016.The result was 39.4°c within range.There were no wrap attribute or variable defects recorded for the lot that would affect wrap temperature.On run day two laboratory investigation report was completed for one hot cell, an individual cell with the upper temperature of 44.7°c, above 44.0° celsius (per spec-23451, effective 28nov2016).The temperature limit for individual cells is 35.8°c to 44.0°c.Each wrap is composed of 16 cells.There were no other reports of hot cells within that wrap or within the batch.The investigation did not identify a laboratory related issue to explain the out of limits result.The lab tested 10 additional wraps and the results for individual cells passed with results of 37.1°c to 41.6°c within the limits.Event report was completed by manufacturing to determine the root cause.The root cause for this event is classified under equipment, mechanical failure.Production operators found brine pump a14 dosing too low.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.The production operators adjusted the pump output and resumed production.Event report determined there was no quality impact to the product or patients' safety.All site investigations were appropriately closed and addressed prior to batch release.An investigation, (b)(4), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019 and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.The device history record for this lot has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving an adverse event/serious/unknown.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer alleges the heat wrap caused a burn while using the heatwrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.No quality issues were identified upon this review of dhr, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures (37.6°c - 41.9°c) per spec-23451, effective date: 28nov2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, (b)(4), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.Upon follow-up, product quality complaints provided the severity of harm as s3 (injury, which could result in the need for medical treatment and hospitalization).Reserve sample evaluation required: yes.Visually inspect retained samples completed: 17may2019.The visual inspection of retain samples included 4 cartons, 8 pouches and the 8 wraps inside.Inspection shows no obvious defects to pouches or wraps.Inspection shows no obvious defects to cartons, pouches or wraps.Retain sample inspection form documented the retain evaluation performed on 17may2019 for an unrelated complaint.Reserve sample testing required: no.Confirmed reserve defect: no.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.Lot trend actions taken: a trend does not exist for this lot.Expedite trend identified: no.Other trend identified: no.Sample status: not available.Site sample status: not received.Sterile product: no.Reasonably suggest device malfunction: no and yes (discrepant information reported).Severity of harm: n/a and s3 (discrepant information reported), repeat investigation: no and yes (discrepant information reported), was capa previously identified no.Regulatory impact: no.Process related: no.Product quality impact: no.Market / clinical impact: no.Design related: no.Full investigation required: no.Summary of investigation and conclusion: based on the complaint narrative, the patient sustained burns and blisters after product use.This is a serious reportable case.I concur with the medical assessment.Root cause/capa final confirmation status: not confirmed.Non-assignable (complaint not confirmed).Stability impact: no.Confirmed reserve defect: no.Lot-specific trend identified: no.Confirmed complement sample defect: n/a -not received.Follow-up(30jul2019): new information received from a product quality complaint group included: investigation results.Follow-up (04aug2019): new information received from product quality complaint group included: severity of harm rating (s3).Follow-up (08oct2019): new information from a contactable consumer includes: updated seriousness (hospitalization), treatment information (none received), event details (burned by them using them correctly), and outcome ("still has the mark (burns) on his back from them;" outcome updated to recovered with sequel).Follow-up (27aug2019): new information received from a product quality complaint group included: summary of investigation and conclusion, sterile: no, additional citi search with different date (02aug2017 through 02aug2019), sample not available, reserve sample evaluation, lot trend assessment, reasonably suggest device malfunction, severity of harm: n/a, and other investigation findings.Follow-up attempts are completed.No further information in expected.Company clinical evaluation comment: based on the information provided, the events of burns second degree and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The above referenced lot number s97473 was recalled on 26apr2019.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall due to out of specification results for high cell temperature that could result potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap applied area.This lot was distributed in the united states and puerto rico with expiry dates of 3/31/2020.
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Manufacturer Narrative
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Summary of investigation: lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.An evaluation of the complaint history confirms that this is the 14th complaint for the sub class adverse event safety request for investigation received at the (site name) site requiring an evaluation for this batch.The previous complaints evaluated were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: responsible site notification date: 26jul2017through 29jul2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 545 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were identified as having a manufacturing related root cause of for adverse event safety request for investigation.The subclass shows an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.Seven complaints were related to batch s97473.None were confirmed.
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Event Description
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He received burns/blisters/skin is discolored where the 3 rocks or heat cells were [burns second degree].The wraps were recalled because of the cell temperatures [device issue].Case description: this is a spontaneous report from a contactable consumer reported for her boyfriend.A 37-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number s97473, expiration date 31mar2020, applied to lower back as needed from 2016 to 2019 for back pain.Medical history included he was injured and couldn't walk.Concomitant medications were none.The patient was injured and used the wraps.He received burns/blisters on back.He used the back pain therapy wraps.The wraps were recalled because of the cell temperatures.He had pictures on his phone of his back.He went to the gas station and couldn't walk.He was having back issues and used the wrap.He still had issues with his back.He got epidural shots and he always used the wraps.Reporter did not know if he received an injection before or after he used the wrap.He still had marks on his back.The skin was discolored where the 3 rocks or heat cells were.He was burned sometime in (b)(6) 2019.The reporter confirmed the patient was burned by using the heatwraps correctly.Hospital admission was involved for the events.The reporter denied the patient received any treatment for the events.He stopped using the wraps in (b)(6) or (b)(6) 2019.The action taken in response to the events of the product was permanently discontinued.He had an mri for his back.The patient was currently under the care of a physician for any medical condition.He classified his skin tone as "colour".He did not have sensitive skin or abnormal skin conditions.The red box was purchased.He used thermacare maybe a couple of hours per day.He previously used thermacare and he did not experience the same problem.He had not previously used other heat products for pain relief.He attached the adhesive to body.He did not engage in exercise while using the product.He checked his skin under the product while wearing thermacare after he was burned.The burn/blister had healed on an unspecified date.He had 3 marks on back from the heat cells.He still has the mark (burns) on his back from them as of the report on (b)(6) 2019.He did contact his doctor to let him know.The outcome of the events was resolved with sequel.According to product quality complaint group: summary of investigation: lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.An evaluation of the complaint history confirms that this is the 14th complaint for the sub class adverse event safety request for investigation received at the (site name) site requiring an evaluation for this batch.The previous complaints evaluated were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: responsible site notification date: 26jul2017through 29jul2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 545 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were identified as having a manufacturing related root cause of for adverse event safety request for investigation.The subclass shows an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.Seven complaints were related to batch s97473.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The remaining recall batches were not reported.Based on this citi customizable search, the trending chart shows an increase in adverse events (aes) for april2019 and may2019 for the subclass of adverse events safety request for investigation for lbh products.Refer to the attached trend chart for lbh adverse event jul2017 to jul2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.These complaints are classified as open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.There is no further action required.Review of the device history record (dhr) for this lot concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this lot indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the lot shows all wraps met the required wrap batch average temperatures (37.6°c to 41.6°c) per spec 23451, effective: 28-nov-2016.The result was 39.4°c within range.There were no wrap attribute or variable defects recorded for the lot that would affect wrap temperature.On run day two laboratory investigation report pr - 1842197 was completed for one hot cell, an individual cell with the upper temperature of 44.7°c, above 44.0° celsius (per spec-23451, effective 28nov2016).The temperature limit for individual cells is 35.8°c to 44.0°c.Each wrap is composed of 16 cells.There were no other reports of hot cells within that wrap or within the batch.The investigation did not identify a laboratory related issue to explain the out of limits result.The lab tested 10 additional wraps and the results for individual cells passed with results of 37.1°c to 41.6°c within the limits.Event report er - 1842208 was completed by manufacturing to determine the root cause.The root cause for this event is classified under equipment, mechanical failure.Production operators found brine pump a14 dosing too low.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.The production operators adjusted the pump output and resumed production.Er - 1842208 determined there was no quality impact to the product or patients' safety.All site investigations were appropriately closed and addressed prior to batch release.An investigation, (b)(4), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019 and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer alleges the heat wrap caused a burn while using the heatwrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.No quality issues were identified upon this review of dhr, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures (37.6°c - 41.9°c) per spec-23451, effective date: 28nov2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, (b)(4), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.Upon follow-up, product quality complaints provided the severity of harm as s3 (injury, which could result in the need for medical treatment and hospitalization).Follow-up(30jul2019): new information received from a product quality complaint group included: investigation results.Follow-up (04aug2019): new information received from product quality complaint group included: severity of harm rating (s3).Follow-up (08oct2019): new information from a contactable consumer includes: updated seriousness (hospitalization), treatment information (none received), event details (burned by them using them correctly), and outcome ("still has the mark (burns) on his back from them;" outcome updated to recovered with sequel).Follow-up attempts are completed.No further information in expected.Company clinical evaluation comment: based on the information provided, the events of burns second degree and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The above referenced lot number s97473 was recalled on 26apr2019.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall due to out of specification results for high cell temperature that could result potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap applied area.This lot was distributed in the united states and puerto rico with expiry dates of 3/31/2020.
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Manufacturer Narrative
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Summary of investigation: lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.An evaluation of the complaint history confirms that this is the 14th complaint for the sub class adverse event safety request for investigation received at the (site name) site requiring an evaluation for this batch.The previous complaints evaluated were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: responsible site notification date: 26jul2017through 29jul2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 545 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were identified as having a manufacturing related root cause of for adverse event safety request for investigation.The subclass shows an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.Seven complaints were related to batch s97473.None were confirmed.
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Event Description
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He received burns/blisters/skin is discolored where the 3 rocks or heat cells were [burns second degree] the wraps were recalled because of the cell temperatures [device issue] case description: this is a spontaneous report from a contactable consumer reported for her boyfriend.A 37-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number s97473, expiration date 31mar2020, applied to lower back as needed from 2016 to 2019 for back pain.Medical history included he was injured and couldn't walk.Concomitant medications were none.The patient was injured and used the wraps.He received burns/blisters on back.He used the back pain therapy wraps.The wraps were recalled because of the cell temperatures.He had pictures on his phone of his back.He went to the gas station and couldn't walk.He was having back issues and used the wrap.He still had issues with his back.He got epidural shots and he always used the wraps.Reporter did not know if he received an injection before or after he used the wrap.He still had marks on his back.The skin was discolored where the 3 rocks or heat cells were.He was burned sometime in mar2019.He stopped using the wraps in mar or apr2019.He had an mri for his back.The patient was currently under the care of a physician for any medical condition.He classified his skin tone as colour.He did not have sensitive skin or abnormal skin conditions.The red box was purchased.He used thermacare maybe a couple of hours per day.He previously used thermacare and he did not experience the same problem.He had not previously used other heat products for pain relief.He attached the adhesive to body.He did not engage in exercise while using the product.He checked his skin under the product while wearing thermacare after he was burned.The burn/blister had healed.He had 3 marks on back from the heat cells.The action taken in response to the events of the product was permanently discontinued.The outcome of the events was resolved.According to product quality complaint group: summary of investigation: lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.An evaluation of the complaint history confirms that this is the 14th complaint for the sub class adverse event safety request for investigation received at the (site name) site requiring an evaluation for this batch.The previous complaints evaluated were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: responsible site notification date: 26jul2017through 29jul2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 545 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were identified as having a manufacturing related root cause of for adverse event safety request for investigation.The subclass shows an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.Seven complaints were related to batch s97473.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The remaining recall batches were not reported.Based on this citi customizable search, the trending chart shows an increase in adverse events (aes) for april2019 and may2019 for the subclass of adverse events safety request for investigation for lbh products.Refer to the attached trend chart for lbh adverse event jul2017 to jul2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.These complaints are classified as open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.There is no further action required.Review of the device history record (dhr) for this lot concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this lot indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the lot shows all wraps met the required wrap batch average temperatures (37.6°c to 41.6°c) per spec 23451, effective: 28-nov-2016.The result was 39.4°c within range.There were no wrap attribute or variable defects recorded for the lot that would affect wrap temperature.On run day two laboratory investigation report pr (b)(4) was completed for one hot cell, an individual cell with the upper temperature of 44.7°c, above 44.0° celsius (per spec-23451, effective 28nov2016).The temperature limit for individual cells is 35.8°c to 44.0°c.Each wrap is composed of 16 cells.There were no other reports of hot cells within that wrap or within the batch.The investigation did not identify a laboratory related issue to explain the out of limits result.The lab tested 10 additional wraps and the results for individual cells passed with results of 37.1°c to 41.6°c within the limits.Event report er - 1842208 was completed by manufacturing to determine the root cause.The root cause for this event is classified under equipment, mechanical failure.Production operators found brine pump a14 dosing too low.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.The production operators adjusted the pump output and resumed production.Er - 1842208 determined there was no quality impact to the product or patients' safety.All site investigations were appropriately closed and addressed prior to batch release.An investigation, pr(b)(6), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019 and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer alleges the heat wrap caused a burn while using the heatwrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.No quality issues were identified upon this review of dhr, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures (37.6°c - 41.9°c) per spec-23451, effective date: 28nov2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, pr2640501, was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.Upon follow-up, product quality complaints provided the severity of harm as s3 (injury, which could result in the need for medical treatment and hospitalization).Follow-up(30jul2019): new information received from a product quality complaint group included: investigation results.Follow-up (04aug2019): new information received from product quality complaint group included: severity of harm rating (s3).Company clinical evaluation comment: based on the information provided, the events of burns second degree and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The above referenced lot number s97473 was recalled on 26apr2019.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall due to out of specification results for high cell temperature that could result potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap applied area.This lot was distributed in the united states and puerto rico with expiry dates of 3/31/2020.
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Manufacturer Narrative
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Summary of investigation: lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.An evaluation of the complaint history confirms that this is the 14th complaint for the sub class adverse event safety request for investigation received at the (site name) site requiring an evaluation for this batch.The previous complaints evaluated were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: responsible site notification date: 26jul2017 through 29jul2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 545 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were identified as having a manufacturing related root cause of for adverse event safety request for investigation.The subclass shows an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.Seven complaints were related to batch s97473.None were confirmed.
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Event Description
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He received burns/blisters/skin is discolored where the 3 rocks or heat cells were [burns second degree].The wraps were recalled because of the cell temperatures [device issue].Case description: this is a spontaneous report from a contactable consumer reported for her boyfriend.A 37-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number s97473, expiration date 31mar2020, applied to lower back as needed from 2016 to 2019 for back pain.Medical history included he was injured and couldn't walk.Concomitant medications were none.The patient was injured and used the wraps.He received burns/blisters on back.He used the back pain therapy wraps.The wraps were recalled because of the cell temperatures.He had pictures on his phone of his back.He went to the gas station and couldn't walk.He was having back issues and used the wrap.He still had issues with his back.He got epidural shots and he always used the wraps.Reporter did not know if he received an injection before or after he used the wrap.He still had marks on his back.The skin was discolored where the 3 rocks or heat cells were.He was burned sometime in (b)(6) 2019.He stopped using the wraps in (b)(6) or (b)(6) 2019.He had an mri for his back.The patient was currently under the care of a physician for any medical condition.He classified his skin tone as colour.He did not have sensitive skin or abnormal skin conditions.The red box was purchased.He used thermacare maybe a couple of hours per day.He previously used thermacare and he did not experience the same problem.He had not previously used other heat products for pain relief.He attached the adhesive to body.He did not engage in exercise while using the product.He checked his skin under the product while wearing thermacare after he was burned.The burn/blister had healed.He had 3 marks on back from the heat cells.The action taken in response to the events of the product was permanently discontinued.The outcome of the events was resolved.According to product quality complaint group: summary of investigation: lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.An evaluation of the complaint history confirms that this is the 14th complaint for the sub class adverse event safety request for investigation received at the (site name) site requiring an evaluation for this batch.The previous complaints evaluated were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: responsible site notification date: 26jul2017 through 29jul2019/manufacturing site: pfizer (site name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The citi customizable search returned a total of 545 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were identified as having a manufacturing related root cause of for adverse event safety request for investigation.The subclass shows an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected\ baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.Seven complaints were related to batch s97473.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The remaining recall batches were not reported.Based on this citi customizable search, the trending chart shows an increase in adverse events (aes) for april2019 and may2019 for the subclass of adverse events safety request for investigation for lbh products.Refer to the attached trend chart for lbh adverse event jul2017 to jul2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.These complaints are classified as open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.There is no further action required.Review of the device history record (dhr) for this lot concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this lot indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the lot shows all wraps met the required wrap batch average temperatures (37.6°c to 41.6°c) per spec 23451, effective: 28-nov-2016.The result was 39.4°c within range.There were no wrap attribute or variable defects recorded for the lot that would affect wrap temperature.On run day two laboratory investigation report pr - 1842197 was completed for one hot cell, an individual cell with the upper temperature of 44.7°c, above 44.0° celsius (per spec-23451, effective 28nov2016).The temperature limit for individual cells is 35.8°c to 44.0°c.Each wrap is composed of 16 cells.There were no other reports of hot cells within that wrap or within the batch.The investigation did not identify a laboratory related issue to explain the out of limits result.The lab tested 10 additional wraps and the results for individual cells passed with results of 37.1°c to 41.6°c within the limits.Event report er - 1842208 was completed by manufacturing to determine the root cause.The root cause for this event is classified under equipment, mechanical failure.Production operators found brine pump a14 dosing too low.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.The production operators adjusted the pump output and resumed production.Er - 1842208 determined there was no quality impact to the product or patients' safety.All site investigations were appropriately closed and addressed prior to batch release.An investigation, pr2640501, was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019 and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer alleges the heat wrap caused a burn while using the heatwrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.No quality issues were identified upon this review of dhr, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures (37.6°c - 41.9°c) per spec-23451, effective date: 28nov2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, pr2640501, was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.Upon follow-up, product quality complaints provided the severity of harm as s3 (injury, which could result in the need for medical treatment and hospitalization).Follow-up(30jul2019): new information received from a product quality complaint group included: investigation results.Follow-up (04aug2019): new information received from product quality complaint group included: severity of harm rating (s3).Company clinical evaluation comment: based on the information provided, the events of burns second degree and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The above referenced lot number s97473 was recalled on 26apr2019.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall due to out of specification results for high cell temperature that could result potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap applied area.This lot was distributed in the united states and puerto rico with expiry dates of 3/31/2020.
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Manufacturer Narrative
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Lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi customizable search, there is not a trend identified for the subclass of adverse events/serious/unknown.The device history record for this lot has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving an adverse event/serious/unknown.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer alleges the heat wrap caused a burn while using the heatwrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.No quality issues were identified upon this review of dhr, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures (37.6°c - 41.9°c) per spec-23451, effective date: 28nov2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, pr2640501, was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.
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Event Description
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Event verbatim [preferred term] he received burns/blisters/skin is discolored where the 3 rocks or heat cells were [burns second degree], the wraps were recalled because of the cell temperatures [device issue], , narrative: this is a spontaneous report from a contactable consumer reported for her boyfriend.A 37-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number s97473, expiration date 31mar2020, applied to lower back as needed from 2016 to 2019 for back pain.Medical history included he was injured and couldn't walk.Concomitant medications were none.The patient was injured and used the wraps.He received burns/blisters on back.He used the back pain therapy wraps.The wraps were recalled because of the cell temperatures.He had pictures on his phone of his back.He went to the gas station and couldn't walk.He was having back issues and used the wrap.He still had issues with his back.He got epidural shots and he always used the wraps.Reporter did not know if he received an injection before or after he used the wrap.He still had marks on his back.The skin was discolored where the 3 rocks or heat cells were.He was burned sometime in (b)(6) 2019.The reporter confirmed the patient was burned by using the heatwraps correctly.Hospital admission was involved for the events.The reporter denied the patient received any treatment for the events.He stopped using the wraps in (b)(6) 2019.The action taken in response to the events of the product was permanently discontinued.He had an mri for his back.The patient was currently under the care of a physician for any medical condition.He classified his skin tone as "colour".He did not have sensitive skin or abnormal skin conditions.The red box was purchased.He used thermacare maybe a couple of hours per day.He previously used thermacare heatwraps and he did not experience the same problem.He had not previously used other heat products for pain relief.He attached the adhesive to body.He did not engage in exercise while using the product.He checked his skin under the product while wearing thermacare after he was burned.The burn/blister had healed on an unspecified date.He had 3 marks on back from the heat cells.He still has the mark (burns) on his back from them as of the report on (b)(6) 2019.He did contact his doctor to let him know.The outcome of the events was resolved with sequel.According to product quality complaint group: lot s97473 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi customizable search, there is not a trend identified for the subclass of adverse events/serious/unknown.The device history record for this lot has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving an adverse event/serious/unknown.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer alleges the heat wrap caused a burn while using the heatwrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.No quality issues were identified upon this review of dhr, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures (37.6°c - 41.9°c) per spec-23451, effective date: 28nov2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, pr2640501, was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.Upon follow-up, product quality complaints provided the severity of harm as s3 (injury, which could result in the need for medical treatment and hospitalization).It was confirmed that severity of harm is assessed as s3 for burn/blisters as the patient developed burn injuries with product use.Follow-up(30jul2019): new information received from a product quality complaint group included: investigation results.Follow-up (04aug2019): new information received from product quality complaint group included: severity of harm rating (s3).Follow-up (08oct2019): new information from a contactable consumer includes: updated seriousness (hospitalization), treatment information (none received), event details (burned by them using them correctly), and outcome ("still has the mark (burns) on his back from them;" outcome updated to recovered with sequel).Follow-up (27aug2019): new information received from a product quality complaint group included: summary of investigation and conclusion, sterile: no, additional citi search with different date (02aug2017 through 02aug2019), sample not available, reserve sample evaluation, lot trend assessment, reasonably suggest device malfunction, severity of harm: n/a, and other investigation findings.Follow-up attempts are completed.No further information in expected.Follow-up (08nov2019): new information received from a product quality complaint group included: it was confirmed that severity of harm is assessed as s3 for burn/blisters as the patient developed burn injuries with product use.Company clinical evaluation comment: based on the information provided, the events of burns second degree and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The above referenced lot number s97473 was recalled on 26apr2019.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall due to out of specification results for high cell temperature that could result potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap applied area.This lot was distributed in the united states and puerto rico with expiry dates of 3/31/2020.Amendment: this follow-up report is being submitted to notify us food and drug administration (fda) that mfr report number 1066015-2019-00212 and mfr report number 1066015-2019-00223 are duplicate.All subsequent follow-up information will be reported under mfr report number 1066015-2019-00212.Mfr report number 1066015-2019-00223 is to be considered as deleted., comment: based on the information provided, the events of burns second degree and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The above referenced lot number s97473 was recalled on 26apr2019.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall due to out of specification results for high cell temperature that could result potential risk of skin injuries such as burns/blisters and/or skin irritation on the wrap applied area.This lot was distributed in the united states and puerto rico with expiry dates of 3/31/2020.
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