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| Lot Number T48927; T48943 |
| Device Problems
Unintended Ejection (1234); Insufficient Heating (1287); Leak/Splash (1354); Unsealed Device Packaging (1444); Material Too Rigid or Stiff (1544); Inadequacy of Device Shape and/or Size (1583)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).Without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Additional information received on 16may2018 from product quality complaint (pqc) group included additional investigation results.The most probable root cause of this event is equipment / mechanical failure.The brine is a solution of salt, sodium thiosulfate pentahydrate and water required for the exothermic reaction responsible for the heat emission of the heatwraps.This solution is added to a chemistry premix in the individual heat pack cells during the manufacturing process.The brine solution is pumped from the dosing pumps to a brine dosing manifold.The outlet of each pump has an individual hose that is connected to the brine dosing manifold.This manifold serves as a connection point for each individual line connecting to the brine dosing carriage.The carriage has a tube fitting and a nozzle to deliver the brine to each product cell.The returned wrap under investigation 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.The area appears to have been left unsealed due to the brine being in the area around the cells preventing them from sealing.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges we.
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Event Description
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Event verbatim [preferred term] the charcoal is now loose and floating around/the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat [device leakage].Case narrative: this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t48927; t48943, expiration date oct2020) from an unspecified date for an unspecified indication.The patient's medical history was not reported.Concomitant medications included unspecified "steroids".On an unspecified date, the patient reported the last one she used, she kept it, and it did something really strange.She has never noticed this happen before but the little heat cells, the charcoal she guesses, but it is the pads that generate the heat to provide relief.They are little odd shaped blocks, but 2 of the individual things have broken off from the material.Now inside the material, the charcoal is now loose and floating around.They haven't leaked, as far as she can tell, out of the overlay of the material.It is noticeable on the inner part for the wrap.She has also noticed the belting, the material is lacking in the stretchability and doesn't hold up for 8 hours like it use to.She also mentioned the product felt smaller and did not stay on properly.The band was thinner and did not work.Action taken with the suspect product was unknown.The patient further described the heatwrap as the shape of the wrap has changed how it goes on the back.The old style was more rectangular shaped and she could move it around the back from one side to the other.Since the change, the band on the wrap is narrower.The velcro connection is not like it was.Clinical outcome of the event was unknown.Additional information received on 11may2018 from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).Without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Additional information received on 16may2018 from product quality complaint (pqc) group included additional investigation results.The most probable root cause of this event is equipment / mechanical failure.The brine is a solution of salt, sodium thiosulfate pentahydrate and water required for the exothermic reaction responsible for the heat emission of the heatwraps.This solution is added to a chemistry premix in the individual heat pack cells during the manufacturing process.The brine solution is pumped from the dosing pumps to a brine dosing manifold.The outlet of each pump has an individual hose that is connected to the brine dosing manifold.This manifold serves as a connection point for each individual line connecting to the brine dosing carriage.The carriage has a tube fitting and a nozzle to deliver the brine to each product cell.The returned wrap under investigation 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.The area appears to have been left unsealed due to the brine being in the area around the cells preventing them from sealing.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.Follow-up (11may2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (16may2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (12mar2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.No follow-up attempts needed.No further information expected.Company clinical evaluation comment the event "the charcoal is now loose and floating around/the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "the charcoal is now loose and floating around/the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] the charcoal is now loose and floating around/the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat [device leakage].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A 73-year-old female patient (age group reported as "adult", weight: 140lb, height: 5'2 1/2") started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t48927; t48943, expiration date oct2020) from an unspecified date for pain lower back.The patient's medical history was not reported.Concomitant medications included unspecified "steroids".On an unspecified date, the patient reported the last one she used, she kept it, and it did something really strange.She has never noticed this happen before but the little heat cells, the charcoal she guesses, but it is the pads that generate the heat to provide relief.They are little odd shaped blocks, but 2 of the individual things have broken off from the material.Now inside the material, the charcoal is now loose and floating around.They haven't leaked, as far as she can tell, out of the overlay of the material.It is noticeable on the inner part for the wrap.Later it was reported that "the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat." she "self treated, stop using".There was no hospital admission involved, and no treatment received.She has also noticed the belting, the material is lacking in the stretchability and doesn't hold up for 8 hours like it use to.She also mentioned the product felt smaller and did not stay on properly.The band was thinner and did not work.The patient further described the heatwrap as the shape of the wrap has changed how it goes on the back.The old style was more rectangular shaped and she could move it around the back from one side to the other.Since the change, the band on the wrap is narrower.The velcro connection is not like it was.The patient continuously was taking after checking item one package at a time.Also reported that "you made product smaller (pad and band/both charcoal pad and band)." action taken with the suspect product was dose not changed.Clinical outcome of the event was recovered, reported as "fine now".Additional information received on 11may2018 from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).Without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Additional information received on 16may2018 from product quality complaint (pqc) group included additional investigation results.The most probable root cause of this event is equipment / mechanical failure.The brine is a solution of salt, sodium thiosulfate pentahydrate and water required for the exothermic reaction responsible for the heat emission of the heatwraps.This solution is added to a chemistry premix in the individual heat pack cells during the manufacturing process.The brine solution is pumped from the dosing pumps to a brine dosing manifold.The outlet of each pump has an individual hose that is connected to the brine dosing manifold.This manifold serves as a connection point for each individual line connecting to the brine dosing carriage.The carriage has a tube fitting and a nozzle to deliver the brine to each product cell.The returned wrap under investigation 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.The area appears to have been left unsealed due to the brine being in the area around the cells preventing them from sealing.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.Follow-up (11may2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (16may2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (12mar2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.No follow-up attempts needed.No further information expected.Follow- up (06dec2019): new information received from a contactable consumer included: patient's age, age group, weight and height, indication, no hospitalization, no treatment, action taken, outcome and information "the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat., you made product smaller (pad and band/both charcoal pad and band)".Follow-up attempts completed.No further information expected.Company clinical evaluation comment the event "the charcoal is now loose and floating around/the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.The most probable root cause of this event is equipment / mechanical failure., comment: the event "the charcoal is now loose and floating around/the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.The most probable root cause of this event is equipment / mechanical failure.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).Without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Additional information received on 16may2018 from product quality complaint (pqc) group included additional investigation results.The most probable root cause of this event is equipment / mechanical failure.The brine is a solution of salt, sodium thiosulfate pentahydrate and water required for the exothermic reaction responsible for the heat emission of the heatwraps.This solution is added to a chemistry premix in the individual heat pack cells during the manufacturing process.The brine solution is pumped from the dosing pumps to a brine dosing manifold.The outlet of each pump has an individual hose that is connected to the brine dosing manifold.This manifold serves as a connection point for each individual line connecting to the brine dosing carriage.The carriage has a tube fitting and a nozzle to deliver the brine to each product cell.The returned wrap under investigation 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.The area appears to have been left unsealed due to the brine being in the area around the cells preventing them from sealing.This incident impacted directly one cell; however, the brine out of the cell flowed to the next cell causing that both cell edges we.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).Without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Additional information received on 16may2018 from product quality complaint (pqc) group included additional investigation results.The most probable root cause of this event is equipment / mechanical failure.The brine is a solution of salt, sodium thiosulfate pentahydrate and water required for the exothermic reaction responsible for the heat emission of the heatwraps.This solution is added to a chemistry premix in the individual heat pack cells during the manufacturing process.The brine solution is pumped from the dosing pumps to a brine dosing manifold.The outlet of each pump has an individual hose that is connected to the brine dosing manifold.This manifold serves as a connection point for each individual line connecting to the brine dosing carriage.The carriage has a tube fitting and a nozzle to deliver the brine to each product cell.The returned wrap under investigation 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.The area appears to have been left unsealed due to the brine being in the area around the cells preventing them from sealing.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.Corrective actions: there is no market action recommended.Batch t48943 met all product release criteria and it will remain in release status.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".This investigation recommends no further actions to be taken for batch t48943.Preventive actions: 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.Pr-# is in progress.Due date: (b)(6) 2018.Work orders (wo) (b)(4) (b-line) and (b)(4) (m-line) were issued to inspect and clean the brine carriage nozzles in both lines.This is considered a mitigation action until the pm program is implemented.The wos are programmed to be done in (b)(6) 2018.In addition to meet the requirements of the pqs (b)(4) "control of manufacturing and packaging defects non-sterile", the in-process attribute quality checks sampling frequency intervals were changed from every 10 minutes to every 6 minutes to help monitor the batch real-time and allow reaction to defect issues before the entire batch is processed.This change was implemented on 28mar2018.Returned sample was received at site on 13apr2018.
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Event Description
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Event verbatim [preferred term], the charcoal is now loose and floating around/the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat [device leakage].Narrative: this is a spontaneous report from a contactable consumer.A 71-year-old female patient (age group reported as "adult", weight: 140lb, height: 5'2 1/2") started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t48927; t48943, expiration date oct2020) from an unspecified date for pain lower back.The patient's medical history was not reported.Concomitant medications included unspecified "steroids".On an unspecified date, the patient reported the last one she used, she kept it, and it did something really strange.She has never noticed this happen before but the little heat cells, the charcoal she guesses, but it is the pads that generate the heat to provide relief.They are little odd shaped blocks, but 2 of the individual things have broken off from the material.Now inside the material, the charcoal is now loose and floating around.They haven't leaked, as far as she can tell, out of the overlay of the material.It is noticeable on the inner part for the wrap.Later it was reported that "the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat." she "self treated, stop using".There was no hospital admission involved, and no treatment received.She has also noticed the belting, the material is lacking in the stretchability and doesn't hold up for 8 hours like it use to.She also mentioned the product felt smaller and did not stay on properly.The band was thinner and did not work.The patient further described the heatwrap as the shape of the wrap has changed how it goes on the back.The old style was more rectangular shaped and she could move it around the back from one side to the other.Since the change, the band on the wrap is narrower.The velcro connection is not like it was.The patient continuously was taking after checking item one package at a time.Also reported that "you made product smaller (pad and band/both charcoal pad and band)." action taken with the suspect product was dose not changed.Clinical outcome of the event was recovered, reported as "fine now".Additional information received on 11may2018 from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).Without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Additional information received on 16may2018 from product quality complaint (pqc) group included additional investigation results.The most probable root cause of this event is equipment / mechanical failure.The brine is a solution of salt, sodium thiosulfate pentahydrate and water required for the exothermic reaction responsible for the heat emission of the heatwraps.This solution is added to a chemistry premix in the individual heat pack cells during the manufacturing process.The brine solution is pumped from the dosing pumps to a brine dosing manifold.The outlet of each pump has an individual hose that is connected to the brine dosing manifold.This manifold serves as a connection point for each individual line connecting to the brine dosing carriage.The carriage has a tube fitting and a nozzle to deliver the brine to each product cell.The returned wrap under investigation 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.The area appears to have been left unsealed due to the brine being in the area around the cells preventing them from sealing.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.Corrective actions: there is no market action recommended.Batch t48943 met all product release criteria and it will remain in release status.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".This investigation recommends no further actions to be taken for batch t48943.Preventive actions: 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.Pr-# is in progress.Due date: (b)(6) 2018.Work orders (wo) (b)(4)(b-line) and (b)(4)(m-line) were issued to inspect and clean the brine carriage nozzles in both lines.This is considered a mitigation action until the pm program is implemented.The wos are programmed to be done in (b)(6) 2018.In addition to meet the requirements of the pqs (b)(4) "control of manufacturing and packaging defects non-sterile", the in-process attribute quality checks sampling frequency intervals were changed from every 10 minutes to every 6 minutes to help monitor the batch real-time and allow reaction to defect issues before the entire batch is processed.This change was implemented on 28mar2018.Returned sample was received at site on 13apr2018.Follow-up (11may2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (16may2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (12mar2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.No follow-up attempts needed.No further information expected.Follow- up (06dec2019): new information received from a contactable consumer included: patient's age, age group, weight and height, indication, no hospitalization, no treatment, action taken, outcome and information "the product was cracking up and leaking out/the individual membrane that carry the heat cells were breaking and thus did not retain heat., you made product smaller (pad and band/both charcoal pad and band)".Follow-up attempts completed.No further information expected.Amendment: this follow-up report is being submitted to amend previously reported information: returned sample was received at site on 13apr2018.Follow-up attempts are completed.No further information is expected.
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Search Alerts/Recalls
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