|
|
| Lot Number 9122RA |
| Device Problems
Insufficient Heating (1287); Excessive Heating (4030)
|
| Patient Problem
Burn, Thermal (2530)
|
| Event Date 12/20/2019 |
|
Event Type
Injury
|
|
Event Description
|
|
Thermacare were starting to burn/had a red mark/skin reacting to something [thermal burn], thermacare were starting to burn/3 of the 5 wraps they didn't stay warm, they just were burning hot and then they burned out, states she knew something was wrong with the product [device issue], caller states it wasn't going to work [device ineffective].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number 9122ra, expiration date jan2022, upc (b)(4), from 2014 at 1 wrap at a time across the back for lower back pain.Medical history included diabetes, she has problems with feeling and pain from an unknown date, disabled from an unknown date, osteoarthritis from an unknown date, and fibromyalgia from an unknown date.There were no concomitant medications.The patient experienced thermacare were starting to burn on (b)(6) 2019 with outcome of recovered on (b)(6) 2019, skin reacting to something on (b)(6) 2019 with outcome of recovered on (b)(6) 2019, had a red mark on (b)(6) 2019 with outcome of recovered on (b)(6) 2019, and caller states it wasn't going to work on (b)(6) 2019 with outcome of unknown.The patient stated for some reason they were starting to burn.It wasn't like all of them, just her skin reacting to something.They were just the burning disc and were not heat you could put against your skin.She put a wrap on at 11 pm; her shift ended at 5:30 the next morning.She stated she only had the wrap on for first two hours of her shift.She stated she couldn't take the burning.She states she took the wrap off and it took the third package for one of the heat wraps to finally work.She stated when she got home on (b)(6) 2019 she tried a wrap for a second time, a little earlier in the evening.She stated it wasn't going to work so she tried the third one at 1 am on (b)(6) 2019 and that one worked fine.The patient stated she stands a lot while at work and the wraps help her lower back pain and help keep her warm.The patient stated her reaction receptors, the feeling that the wraps didn't even last, that 3 of the 5 wraps they didn't stay warm, they just were burning hot and then they burned out, states she knew something was wrong with the product.She took the wraps off; states she had a red mark and then it dissipated once she took off the wrap and waited a couple of hours.She put a little neosporin on her back.The patient stated that 4 of the 10 wraps were bad.The action taken with thermacare heatwrap was unknown.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 thermal burn and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective is non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of thermal burn and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective is non-serious.The events are medically assessed as associated with the use of the device.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] thermacare were starting to burn/had a red mark/skin reacting to something [thermal burn], thermacare were starting to burn/3 of the 5 wraps they didn't stay warm, they just were burning hot and then they burned out, states she knew something was wrong with the product [device issue] , caller states it wasn't going to work [device ineffective],.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 47-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number 9122ra, expiration date jan2022, upc 305733010389, from 2014 at 1 wrap at a time across the back for lower back pain.Medical history included ongoing diabetes (she has problems with feeling and pain), disabled from an unknown date, osteoarthritis from an unknown date, and fibromyalgia from an unknown date.There were no concomitant medications.The patient experienced thermacare were starting to burn, skin reacting to something and had a red mark on (b)(6) 2019 with outcome of recovered on (b)(6) 2019, and caller stated it was not going to work on (b)(6) 2019 with outcome of unknown.The patient stated for some reason they were starting to burn.It was not like all of them, just her skin reacting to something.They were just the burning disc and were not heat you could put against your skin.She put a wrap on at 11 pm; her shift ended at 5:30 the next morning.She stated she only had the wrap on for first two hours of her shift.She stated she could not take the burning.She stated she took the wrap off and it took the third package for one of the heat wraps to finally work.She stated when she got home on (b)(6) 2019 she tried a wrap for a second time, a little earlier in the evening.She stated it was not going to work so she tried the third one at 1 am on (b)(6) 2019 and that one worked fine.The patient stated she stands a lot while at work and the wraps help her lower back pain and help keep her warm.The patient stated her reaction receptors, the feeling that the wraps didn't even last, that 3 of the 5 wraps they did not stay warm, they just were burning hot and then they burned out, states she knew something was wrong with the product.She took the wraps off; states she had a red mark and then it dissipated once she took off the wrap and waited a couple of hours.She put a little neosporin on her back.The patient stated that 4 of the 10 wraps were bad.A sample of the product was available to be returned for evaluation.The action taken with thermacare heatwrap was unknown.According to product quality complaint group: summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed).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 the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.There was no trend identified for the lot for the subclass of too hot.There was an increase in complaints received in may 2019 for wrap/patch/pad: too hot, due to the recall in (b)(6) 2019 for lbh batches s97473, s00639, s23902, w37940.As a result of the increase of complaints in may 2019 and the emerging trend identified in may; investigation (b)(4) was completed for the trend of too hot for lbh.Batches involved in investigation (b)(4) were w59249, ad3849 and w91244.(b)(4) determined that the customer complaint trend observed for the too hot wrap defect was caused as a consequence of the recall notification provided to the customers related to lbh batches s97473, s00639, s23902, w37940 which is associated to a hot cell defect.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the albany site requiring an evaluation for this lot.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.The sample had not been received by the site.Additional information received from quality complaint group: rsnbly suggest device malfunction was yes and severity of harm was s1 for complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Summary is as below: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is sl no harm to customer.Follow-up (17jan2020): new information received from a product quality complaint group included: investigation results.Follow-up (06feb2020): new information received from a product quality complaint group includes additional investigation results.Company clinical evaluation comment: based on the information provided, the events of thermal burn and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of thermal burn and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Manufacturer Narrative
|
|
Summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed).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 the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.There was no trend identified for the lot for the subclass of too hot.There was an increase in complaints received in may 2019 for wrap/patch/pad: too hot, due to the recall in (b)(6) 2019 for lbh batches s97473, s00639, s23902, w37940.As a result of the increase of complaints in may 2019 and the emerging trend identified in may; investigation (b)(4) was completed for the trend of too hot for lbh.Batches involved in investigation (b)(4) were w59249, ad3849 and w91244.(b)(4) determined that the customer complaint trend observed for the too hot wrap defect was caused as a consequence of the recall notification provided to the customers related to lbh batches s97473, s00639, s23902, w37940 which is associated to a hot cell defect.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the albany site requiring an evaluation for this lot.No trend was identified.On the basis of this eva.
|
| |
|
Manufacturer Narrative
|
|
Summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed).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 the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.There was no trend identified for the lot for the subclass of too hot.There was an increase in complaints received in may 2019 for wrap/patch/pad: too hot, due to the recall in april 2019 for lbh batches s97473, s00639, s23902, w37940.As a result of the increase of complaints in may 2019 and the emerging trend identified in may; investigation pr-3938189 was completed for the trend of too hot for lbh.Batches involved in investigation (b)(4) were w59249, ad3849 and w91244.(b)(4) determined that the customer complaint trend observed for the too hot wrap defect was caused as a consequence of the recall notification provided to the customers related to lbh batches s97473, s00639, s23902, w37940 which is associated to a hot cell defect.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the albany site requiring an evaluation for this lot.No trend was identified.On the basis of this.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] thermacare were starting to burn/had a red mark/skin reacting to something [thermal burn] , thermacare were starting to burn/3 of the 5 wraps they didn't stay warm, they just were burning hot and then they burned out, states she knew something was wrong with the product [device issue] , caller states it wasn't going to work [device ineffective].Case narrative:this is a spontaneous report from a contactable consumer.A 47-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number 9122ra, expiration date jan2022, upc 305733010389, from 2014 at 1 wrap at a time across the back for lower back pain.Medical history included ongoing diabetes (she has problems with feeling and pain), disabled from an unknown date, osteoarthritis from an unknown date, and fibromyalgia from an unknown date.There were no concomitant medications.The patient experienced thermacare were starting to burn on (b)(6)2019 with outcome of recovered on (b)(6)2019, skin reacting to something on (b)(6)2019 with outcome of recovered on (b)(6)2019, had a red mark on (b)(6)2019 with outcome of recovered on (b)(6)2019, and caller stated it wasn't going to work on (b)(6)2019 with outcome of unknown.The patient stated for some reason they were starting to burn.It wasn't like all of them, just her skin reacting to something.They were just the burning disc and were not heat you could put against your skin.She put a wrap on at 11 pm; her shift ended at 5:30 the next morning.She stated she only had the wrap on for first two hours of her shift.She stated she couldn't take the burning.She stated she took the wrap off and it took the third package for one of the heat wraps to finally work.She stated when she got home on (b)(6)2019 she tried a wrap for a second time, a little earlier in the evening.She stated it wasn't going to work so she tried the third one at 1 am on (b)(6)2019 and that one worked fine.The patient stated she stands a lot while at work and the wraps help her lower back pain and help keep her warm.The patient stated her reaction receptors, the feeling that the wraps didn't even last, that 3 of the 5 wraps they didn't stay warm, they just were burning hot and then they burned out, states she knew something was wrong with the product.She took the wraps off; states she had a red mark and then it dissipated once she took off the wrap and waited a couple of hours.She put a little neosporin on her back.The patient stated that 4 of the 10 wraps were bad.The action taken with thermacare heatwrap was unknown.According to product quality complaint group: summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed).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 the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.There was no trend identified for the lot for the subclass of too hot.There was an increase in complaints received in may 2019 for wrap/patch/pad: too hot, due to the recall in april 2019 for lbh batches s97473, s00639, s23902, w37940.As a result of the increase of complaints in may 2019 and the emerging trend identified in may; investigation (b)(4) was completed for the trend of too hot for lbh.Batches involved in investigation (b)(4) were w59249, ad3849 and w91244.(b)(4) determined that the customer complaint trend observed for the too hot wrap defect was caused as a consequence of the recall notification provided to the customers related to lbh batches s97473, s00639, s23902, w37940 which is associated to a hot cell defect.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the albany site requiring an evaluation for this lot.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.The sample had not been received by the site.Follow-up (17jan2020): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: based on the information provided, the events of thermal burn and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of thermal burn and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] thermacare were starting to burn/had a red mark/skin reacting to something [thermal burn] , thermacare were starting to burn/3 of the 5 wraps they didn't stay warm, they just were burning hot and then they burned out, states she knew something was wrong with the product [device issue] , caller states it wasn't going to work [device ineffective].Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A 47-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number 9122ra, expiration date jan2022, upc 305733010389, from 2014 at 1 wrap at a time across the back for lower back pain.Medical history included ongoing diabetes (she has problems with feeling and pain), disabled from an unknown date, osteoarthritis from an unknown date, and fibromyalgia from an unknown date.There were no concomitant medications.The patient experienced thermacare were starting to burn, skin reacting to something and had a red mark on (b)(6)2019 with outcome of recovered on (b)(6)2019, and caller stated it wasn't going to work on (b)(6)2019 with outcome of unknown.The patient stated for some reason they were starting to burn.It wasn't like all of them, just her skin reacting to something.They were just the burning disc and were not heat you could put against your skin.She put a wrap on at 11 pm; her shift ended at 5:30 the next morning.She stated she only had the wrap on for first two hours of her shift.She stated she couldn't take the burning.She stated she took the wrap off and it took the third package for one of the heat wraps to finally work.She stated when she got home on (b)(6)2019 she tried a wrap for a second time, a little earlier in the evening.She stated it wasn't going to work so she tried the third one at 1 am on (b)(6)2019 and that one worked fine.The patient stated she stands a lot while at work and the wraps help her lower back pain and help keep her warm.The patient stated her reaction receptors, the feeling that the wraps didn't even last, that 3 of the 5 wraps they didn't stay warm, they just were burning hot and then they burned out, states she knew something was wrong with the product.She took the wraps off; states she had a red mark and then it dissipated once she took off the wrap and waited a couple of hours.She put a little neosporin on her back.The patient stated that 4 of the 10 wraps were bad.A sample of the product was available to be returned for evaluation.The action taken with thermacare heatwrap was unknown.According to product quality complaint group: summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed).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 the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.There was no trend identified for the lot for the subclass of too hot.There was an increase in complaints received in (b)(6)2019 for wrap/patch/pad: too hot, due to the recall in (b)(6) 2019 for lbh batches s97473, s00639, s23902, w37940.As a result of the increase of complaints in (b)(6) 2019 and the emerging trend identified in may; investigation (b)(4) was completed for the trend of too hot for lbh.Batches involved in investigation (b)(4) were w59249, ad3849 and w91244.(b)(4) determined that the customer complaint trend observed for the too hot wrap defect was caused as a consequence of the recall notification provided to the customers related to lbh batches s97473, s00639, s23902, w37940 which is associated to a hot cell defect.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the albany site requiring an evaluation for this lot.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.The sample had not been received by the site.Additional information received from quality complaint group: rsnbly suggest device malfunction was yes and severity of harm was s1 for complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Summary is as below: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Additional information received from quality complaint group: summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, "caller states she couldn't take the burning her skin reacting to something".The cause of the consumer stating the wrap caused her skin reacting to something, is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.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.The product quality for the batch is not impacted by this complaint.Pr state: closed.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.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.Site sample status was not received.Follow-up (17jan2020): new information received from a product quality complaint group included: investigation results.Follow-up (06feb2020): new information received from a product quality complaint group includes additional investigation results.Follow-up (17feb2020): new information received from a product quality complaint group includes additional investigation results, comment: based on the information provided, the events of thermal burn and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Manufacturer Narrative
|
|
Summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed).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 the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.There was no trend identified for the lot for the subclass of too hot.There was an increase in complaints received in (b)(6)2019 for wrap/patch/pad: too hot, due to the recall in (b)(6) 2019 for lbh batches s97473, s00639, s23902, w37940.As a result of the increase of complaints in (b)(6) 2019 and the emerging trend identified in may; investigation (b)(4) was completed for the trend of too hot for lbh.Batches involved in investigation (b)(4)were w59249, ad3849 and w91244.(b)(4) determined that the customer complaint trend observed for the too hot wrap defect was caused as a consequence of the recall notification provided to the customers related to lbh batches s97473, s00639, s23902, w37940 which is associated to a hot cell defect.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the albany site requiring an evaluation for this lot.No trend was identified.On the basis of this.
|
| |
|
Event Description
|
|
Event verbatim [preferred term].Thermacare were starting to burn/had a red mark/skin reacting to something [thermal burn], thermacare were starting to burn/3 of the 5 wraps they didn't stay warm, they just were burning hot and then they burned out, states she knew something was wrong with the product [device issue], caller states it wasn't going to work [device ineffective].Narrative: this is a spontaneous report from a contactable consumer reporting for herself.A 47-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number 9122ra, expiration date jan2022, upc (b)(4), from 2014 at 1 wrap at a time across the back for lower back pain.Medical history included ongoing diabetes (she has problems with feeling and pain), disabled from an unknown date, osteoarthritis from an unknown date, and fibromyalgia from an unknown date.There were no concomitant medications.The patient experienced thermacare were starting to burn, skin reacting to something and had a red mark on (b)(6) 2019 with outcome of recovered on (b)(6) 2019, and caller stated it wasn't going to work on (b)(6) 2019 with outcome of unknown.The patient stated for some reason they were starting to burn.It wasn't like all of them, just her skin reacting to something.They were just the burning disc and were not heat you could put against your skin.She put a wrap on at 11 pm; her shift ended at 5:30 the next morning.She stated she only had the wrap on for first two hours of her shift.She stated she couldn't take the burning.She stated she took the wrap off and it took the third package for one of the heat wraps to finally work.She stated when she got home on (b)(6) 2019 she tried a wrap for a second time, a little earlier in the evening.She stated it wasn't going to work so she tried the third one at 1 am on (b)(6) 2019 and that one worked fine.The patient stated she stands a lot while at work and the wraps help her lower back pain and help keep her warm.The patient stated her reaction receptors, the feeling that the wraps didn't even last, that 3 of the 5 wraps they didn't stay warm, they just were burning hot and then they burned out, states she knew something was wrong with the product.She took the wraps off; states she had a red mark and then it dissipated once she took off the wrap and waited a couple of hours.She put a little neosporin on her back.The patient stated that 4 of the 10 wraps were bad.A sample of the product was available to be returned for evaluation.The action taken with thermacare heatwrap was unknown.According to product quality complaint group: summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed).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 the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.There was no trend identified for the lot for the subclass of too hot.There was an increase in complaints received in may 2019 for wrap/patch/pad: too hot, due to the recall in april 2019 for lbh batches s97473, s00639, s23902, w37940.As a result of the increase of complaints in may 2019 and the emerging trend identified in may; investigation (b)(4) was completed for the trend of too hot for lbh.Batches involved in investigation (b)(4) were w59249, ad3849 and w91244.(b)(4) determined that the customer complaint trend observed for the too hot wrap defect was caused as a consequence of the recall notification provided to the customers related to lbh batches s97473, s00639, s23902, w37940 which is associated to a hot cell defect.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the albany site requiring an evaluation for this lot.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search an emerging trend was identified in may for the subclass of too hot for lbh products, (see attached trending graph lbh wrap patch pad too hot 27-dec-2016 through 27-dec-2019.This investigation was reopened on 07-oct-2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from (b)(4), complaint trending guidelines, effective dates 19-nov-2019 and 24-feb-2020.A notification of nonconformance was opened (b)(4).This deviation will not change the conclusion of the investigation.The sample had not been received by the site.Additional information received from quality complaint group: rsnbly suggest device malfunction was yes and severity of harm was s1 for complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Summary is as below: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Additional information received from quality complaint group: summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, "caller states she couldn't take the burning her skin reacting to something".The cause of the consumer stating the wrap caused her skin reacting to something, is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.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.The product quality for the batch is not impacted by this complaint.Pr state: closed.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.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: 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 event/serious/unknown.Refer to the attached 36 month trend chart attached lbh ae serious unknown 27-dec-2016 to 27-dec-2019.This investigation was reopened on 07-oct-2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from (b)(4), complaint trending guidelines, effective dates 19-nov-2019 and 24-feb-2020.A notification of nonconformance was opened (b)(4).This deviation will not change the conclusion of the investigation.Site sample status was not received.Follow-up (17jan2020): new information received from a product quality complaint group included: investigation results.Follow-up (06feb2020): new information received from a product quality complaint group includes additional investigation results.Follow-up (17feb2020): new information received from a product quality complaint group includes additional investigation results.Follow-up (28feb2020): follow-up attempts are completed.No further information is expected.Follow-up (08oct2020 and 08oct2020): new information received from a product quality complaint group included: updated trend information.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of thermal burn and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Manufacturer Narrative
|
|
Summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed).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 the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.There was no trend identified for the lot for the subclass of too hot.There was an increase in complaints received in may 2019 for wrap/patch/pad: too hot, due to the recall in april 2019 for lbh batches s97473, s00639, s23902, w37940.As a result of the increase of complaints in may 2019 and the emerging trend identified in may; investigation (b)(4) was completed for the trend of too hot for lbh.Batches involved in investigation (b)(4) were w59249, ad3849 and w91244.(b)(4)determined that the customer complaint trend observed for the too hot wrap defect was caused as a consequence of the recall notification provided to the customers related to lbh batches s97473, s00639, s23902, w37940 which is associated to a hot cell defect.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the albany site requiring an evaluation for this lot.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search an emerging trend was identified in may for the subclass of too hot for lbh products, (see attached trending graph lbh wrap patch pad too hot 27-dec-2016 through 27-dec-2019.This investigation was reopened on 07-oct-2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from (b)(4), complaint trending guidelines, effective dates 19-nov-2019 and 24-feb-2020.A notification of nonconformance was opened (b)(4).This deviation will not change the conclusion of the investigation.The sample had not been received by the site.Rsnbly suggest device malfunction was yes and severity of harm was s1 for complaint sub-class: wrap/patch/pad never worked/unusable/can not be reused.Summary is as below: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Summary of investigation: batch 9122ra/ap2351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ap2351 was manufactured as a bulk product, a portion of batch ap2351 was sent to a contractor for packaging into 10 count cartons, the 10 count carton was labeled batch 9122ra by the contractor.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, "caller states she couldn't take the burning her skin reacting to something".The cause of the consumer stating the wrap caused her skin reacting to something, is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.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.The product quality for the batch is not impacted by this complaint.Pr state: closed.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.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: 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 event/serious/unknown.Refer to the attached 36 month trend chart attached lbh ae serious unknown 27-dec-2016 to 27-dec-2019.This investigation was reopened on 07-oct-2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from (b)(4), complaint trending guidelines, effective dates 19-nov-2019 and 24-feb-2020.A notification of nonconformance was opened (b)(4).This deviation will not change the conclusion of the investigation.Site sample status was not received.
|
| |
|
Search Alerts/Recalls
|
|
|
