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| Lot Number F26176 |
| Device Problems
Use of Device Problem (1670); Device Markings/Labelling Problem (2911)
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| Patient Problems
Swelling (2091); Partial thickness (Second Degree) Burn (2694)
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| Event Date 03/10/2020 |
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Event Type
Injury
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Event Description
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Three blisters on back/felt something really hot while using wrap/one spot was still burning her pretty bad/hurting really bad [burns second degree] , read the usage instructions/did not check her skin under the product while wearing thermacare/she attached the adhesive to: body [intentional device misuse] , used expired wrap [expired device used] , read the usage instructions/applied a wrap for backache [intentional device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).An (b)(6) year-old non-pregnant female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number f26176b, expiration date apr2014, udi#: (b)(4), via an unspecified route of administration on (b)(6) 2020 (reported as "(b)(6) 2020", pending clarification) applied to lower back for 6 hours for backache.Medical history included stroke (2 strokes since the end of 2017), macular degeneration from 2016 and ongoing, rheumatoid arthritis (since age 17), ongoing psoriatic arthritis, hysterectomy (since age 28), neuropathy, poor circulation, neck pain and post-menopausal.The patient was currently under the care of a physician for high blood pressure and she saw a heart and arthritis specialists, went to the retina clinic because she was going blind with macular degeneration.The patient classified her skin tone as very light or fair.She didn't have sensitive skin but she had the abnormal skin conditions provided as atopic dermatitis skin allergy.The patient also added that she had psoriasis and she always looked like she was broken out with the measles.She was not sure if it is the measles.She had brown old age spots that looked like measles.Her doctor had ignored this.Concomitant medication included camphor, eucalyptus globulus oil, juniperus virginiana wood oil, menthol, myristica fragrans oil, pinus nigra oil, thymol (vick vapour-rub) on her arms and legs for psoriasis.The patient was also taking other medications which she said her medication list was a mile long and she didn't mess with them or know the stuff that was in them and her daughter took care of her medications.The patient had previously used thermacare heatwraps for a long time but not experienced the same problem.The patient had previously used other heat products for pain relief, clarifying she used a couple of months ago for neck pain and hadn't experienced a problem.The patient stated she had a backache yesterday (b)(6) 2020) and applied a wrap.Suddenly she felt something really hot on (b)(6) 2020.She couldn't see but it hurt.She stated the very bottom of wrap had gotten wet at the very tip from her diaper or pad.It bothered through the night.Today on (b)(6) 2020 she had her neighbor come check her back and she had 3 blisters, clarifying one looked really bad and was opened.Her neighbor applied aloe vera from a plant on the blister.The patient stated she was trying to get up with doctor.It would take a while to get through to the doctor.She couldn't drive and would have to have someone take her to the doctor's office.She was hurting really bad and felt a big bump then she had stuff on her hands.The patient stated she had used thermacare wraps for a long time and had never had this happen before.She stated the wraps were on sale.She bought a lot because she was using so many and wanted to have them.She didn't expect this to happen.The patient realized the expiry was apr2014 and she used the expired wipe on (b)(6) 2020, asking what happened if one used the wraps after expiry.The patient stated the blisters were close to her spine.She said one spot was still burning her pretty bad.The aloe vera should take the burn out.She said one blister was the size of a quarter to a fifty cent piece and the other two were the size of nickels.The patient stated while she was wearing thermacare, she attached the adhesive to: body for 6 hours.The patient did not engage in exercise while using the product.The patient did not check her skin under the product while wearing thermacare and she read the usage instructions on thermacare before she used the product.There was no product remaining as the patient had discarded the product.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event "three blisters on back/felt something really hot while using wrap/one spot was still burning her pretty bad/hurting really bad" was not recovered, of the event "used expired wrap" was recovered with sequel on (b)(6) 2020, of the other event was unknown.Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the events burns second degree, expired device used and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] read the usage instructions/did not check her skin under the product while wearing thermacare/she attached the adhesive to: body [intentional device misuse], used expired wrap [expired device used], three blisters on back/felt something really hot while using wrap/one spot was still burning her pretty bad/hurting really bad [burns second degree], , narrative: this is a spontaneous report from two contactable consumers (one was patient).An 89-year-old non-pregnant female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number f26176, expiration date apr2014, udi#: (b)(4), via an unspecified route of administration on (b)(6) 2020 (reported as "(b)(6) 2020", pending clarification) applied to lower back for 6 hours for backache.Medical history included stroke (2 strokes since the end of 2017), macular degeneration from 2016 and ongoing, rheumatoid arthritis (since age 17), ongoing psoriatic arthritis, hysterectomy (since age 28), neuropathy, poor circulation, neck pain and ongoing post-menopausal.The patient was currently under the care of a physician for high blood pressure and she saw a heart and arthritis specialists, went to the retina clinic because she was going blind with macular degeneration.The patient classified her skin tone as very light or fair.She didn't have sensitive skin but she had the abnormal skin conditions provided as atopic dermatitis skin allergy.The patient also added that she had psoriasis and she always looked like she was broken out with the measles.She was not sure if it is the measles.She had brown old age spots that looked like measles.Her doctor had ignored this.Concomitant medication included camphor, eucalyptus globulus oil, juniperus virginiana wood oil, menthol, myristica fragrans oil, pinus nigra oil, thymol (vick vapour-rub) on her arms and legs for psoriasis.The patient was also taking other medications which she said her medication list was a mile long and she didn't mess with them or know the stuff that was in them and her daughter took care of her medications.The patient had previously used thermacare heatwraps for a long time but not experienced the same problem.The patient had previously used other heat products for pain relief, clarifying she used a couple of months ago for neck pain and hadn't experienced a problem.The patient stated she had a backache yesterday ((b)(6) 2020) and applied a wrap.Suddenly she felt something really hot on (b)(6)2020.She couldn't see but it hurt.She stated the very bottom of wrap had gotten wet at the very tip from her diaper or pad.It bothered through the night.Today on (b)(6) 2020 she had her neighbor come check her back and she had 3 blisters, clarifying one looked really bad and was opened.Her neighbor applied aloe vera from a plant on the blister.The patient stated she was trying to get up with doctor.It would take a while to get through to the doctor.She couldn't drive and would have to have someone take her to the doctor's office.She was hurting really bad and felt a big bump then she had stuff on her hands.The patient stated she had used thermacare wraps for a long time and had never had this happen before.She stated the wraps were on sale.She bought a lot because she was using so many and wanted to have them.She didn't expect this to happen.The patient realized the expiry was apr2014 and she used the expired wipe on (b)(6) 2020, asking what happened if one used the wraps after expiry.The patient stated the blisters were close to her spine.She said one spot was still burning her pretty bad.The aloe vera should take the burn out.She said one blister was the size of a quarter to a fifty cent piece and the other two were the size of nickels.The patient stated while she was wearing thermacare, she attached the adhesive to: body for 6 hours.The patient did not engage in exercise while using the product.The patient did not check her skin under the product while wearing thermacare and she read the usage instructions on thermacare before she used the product.There was no product remaining as the patient had discarded the product.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event "three blisters on back/felt something really hot while using wrap/one spot was still burning her pretty bad/hurting really bad" was not recovered, of the event "used expired wrap" was recovered with sequel on (b)(6) 2020, of the other event was unknown.According to product quality complaint group: severity of harm is s3.Site had not received sample.Batch f26176 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (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).Consumer reports "blisters developed while wearing wrap." the cause of the consumer developing "blisters" is inconclusive.The review of records does not provide evidence to support the 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 and release testing data.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the subclass adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Follow-up (17mar2020): new information reported from a contactable consumer includes: additional reporter added.Follow-up (27apr2020): new information received from product quality complaint group includes investigation results.Amendment: this follow-up report is being submitted to amend previously reported information: the event 'read the usage instructions/applied a wrap for backache' was deleted.
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Manufacturer Narrative
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Batch f26176 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (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).Consumer reports "blisters developed while wearing wrap." the cause of the consumer developing "blisters¿ is inconclusive.The review of records does not provide evidence to support the 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 and release testing data.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the subclass adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.
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Event Description
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Event verbatim [preferred term] three blisters on back/felt something really hot while using wrap/one spot was still burning her pretty bad/hurting really bad [burns second degree] , read the usage instructions/did not check her skin under the product while wearing thermacare/she attached the adhesive to: body [intentional device misuse] , used expired wrap [expired device used] , read the usage instructions/applied a wrap for backache [intentional device use issue] ,.Case narrative:this is a spontaneous report from two contactable consumers (one was patient).An 89-year-old non-pregnant female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number f26176b, expiration date apr2014, udi#: (b)(4), via an unspecified route of administration on (b)(6) 2020 (reported as "(b)(6) 2020", pending clarification) applied to lower back for 6 hours for backache.Medical history included stroke (2 strokes since the end of 2017), macular degeneration from 2016 and ongoing, rheumatoid arthritis (since age 17), ongoing psoriatic arthritis, hysterectomy (since age 28), neuropathy, poor circulation, neck pain and ongoing post-menopausal.The patient was currently under the care of a physician for high blood pressure and she saw a heart and arthritis specialists, went to the retina clinic because she was going blind with macular degeneration.The patient classified her skin tone as very light or fair.She didn't have sensitive skin but she had the abnormal skin conditions provided as atopic dermatitis skin allergy.The patient also added that she had psoriasis and she always looked like she was broken out with the measles.She was not sure if it is the measles.She had brown old age spots that looked like measles.Her doctor had ignored this.Concomitant medication included camphor, eucalyptus globulus oil, juniperus virginiana wood oil, menthol, myristica fragrans oil, pinus nigra oil, thymol (vick vapour-rub) on her arms and legs for psoriasis.The patient was also taking other medications which she said her medication list was a mile long and she didn't mess with them or know the stuff that was in them and her daughter took care of her medications.The patient had previously used thermacare heatwraps for a long time but not experienced the same problem.The patient had previously used other heat products for pain relief, clarifying she used a couple of months ago for neck pain and hadn't experienced a problem.The patient stated she had a backache yesterday ((b)(6) 2020) and applied a wrap.Suddenly she felt something really hot on (b)(6) 2020.She couldn't see but it hurt.She stated the very bottom of wrap had gotten wet at the very tip from her diaper or pad.It bothered through the night.Today on (b)(6) 2020 she had her neighbor come check her back and she had 3 blisters, clarifying one looked really bad and was opened.Her neighbor applied aloe vera from a plant on the blister.The patient stated she was trying to get up with doctor.It would take a while to get through to the doctor.She couldn't drive and would have to have someone take her to the doctor's office.She was hurting really bad and felt a big bump then she had stuff on her hands.The patient stated she had used thermacare wraps for a long time and had never had this happen before.She stated the wraps were on sale.She bought a lot because she was using so many and wanted to have them.She didn't expect this to happen.The patient realized the expiry was (b)(6) 2014 and she used the expired wipe on (b)(6) 2020, asking what happened if one used the wraps after expiry.The patient stated the blisters were close to her spine.She said one spot was still burning her pretty bad.The aloe vera should take the burn out.She said one blister was the size of a quarter to a fifty cent piece and the other two were the size of nickels.The patient stated while she was wearing thermacare, she attached the adhesive to: body for 6 hours.The patient did not engage in exercise while using the product.The patient did not check her skin under the product while wearing thermacare and she read the usage instructions on thermacare before she used the product.There was no product remaining as the patient had discarded the product.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event "three blisters on back/felt something really hot while using wrap/one spot was still burning her pretty bad/hurting really bad" was not recovered, of the event "used expired wrap" was recovered with sequel on (b)(6) 2020, of the other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2020): new information reported from a contactable consumer includes: additional reporter added., comment: based on the information provided, the events burns second degree, expired device used and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term].Read the usage instructions/did not check her skin under the product while wearing thermacare/she attached the adhesive to: body [intentional device misuse], used expired wrap [expired device used], three blisters on back/felt something really hot while using wrap/one spot was still burning her pretty bad/hurting really bad [burns second degree], read the usage instructions/applied a wrap for backache [intentional device use issue].Narrative: this is a spontaneous report from two contactable consumers (one was patient).An 89-year-old non-pregnant female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number f26176, expiration date apr2014, udi#: (b)(4), via an unspecified route of administration on (b)(6) 2020 (reported as "(b)(6) 2020, pending clarification) applied to lower back for 6 hours for backache.Medical history included stroke (2 strokes since the end of 2017), macular degeneration from 2016 and ongoing, rheumatoid arthritis (since age 17), ongoing psoriatic arthritis, hysterectomy (since age 28), neuropathy, poor circulation, neck pain and ongoing post-menopausal.The patient was currently under the care of a physician for high blood pressure and she saw a heart and arthritis specialists, went to the retina clinic because she was going blind with macular degeneration.The patient classified her skin tone as very light or fair.She didn't have sensitive skin but she had the abnormal skin conditions provided as atopic dermatitis skin allergy.The patient also added that she had psoriasis and she always looked like she was broken out with the measles.She was not sure if it is the measles.She had brown old age spots that looked like measles.Her doctor had ignored this.Concomitant medication included camphor, eucalyptus globulus oil, juniperus virginiana wood oil, menthol, myristica fragrans oil, pinus nigra oil, thymol (vick vapour-rub) on her arms and legs for psoriasis.The patient was also taking other medications which she said her medication list was a mile long and she didn't mess with them or know the stuff that was in them and her daughter took care of her medications.The patient had previously used thermacare heatwraps for a long time but not experienced the same problem.The patient had previously used other heat products for pain relief, clarifying she used a couple of months ago for neck pain and hadn't experienced a problem.The patient stated she had a backache yesterday (b)(6) 2020 and applied a wrap.Suddenly she felt something really hot on (b)(6) 2020.She couldn't see but it hurt.She stated the very bottom of wrap had gotten wet at the very tip from her diaper or pad.It bothered through the night.Today on (b)(6) 2020 she had her neighbor come check her back and she had 3 blisters, clarifying one looked really bad and was opened.Her neighbor applied aloe vera from a plant on the blister.The patient stated she was trying to get up with doctor.It would take a while to get through to the doctor.She couldn't drive and would have to have someone take her to the doctor's office.She was hurting really bad and felt a big bump then she had stuff on her hands.The patient stated she had used thermacare wraps for a long time and had never had this happen before.She stated the wraps were on sale.She bought a lot because she was using so many and wanted to have them.She didn't expect this to happen.The patient realized the expiry was apr2014 and she used the expired wipe on (b)(6) 2020, asking what happened if one used the wraps after expiry.The patient stated the blisters were close to her spine.She said one spot was still burning her pretty bad.The aloe vera should take the burn out.She said one blister was the size of a quarter to a fifty cent piece and the other two were the size of nickels.The patient stated while she was wearing thermacare, she attached the adhesive to: body for 6 hours.The patient did not engage in exercise while using the product.The patient did not check her skin under the product while wearing thermacare and she read the usage instructions on thermacare before she used the product.There was no product remaining as the patient had discarded the product.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event "three blisters on back/felt something really hot while using wrap/one spot was still burning her pretty bad/hurting really bad" was not recovered, of the event "used expired wrap" was recovered with sequel on (b)(6) 2020, of the other events was unknown.According to product quality complaint group: severity of harm is s3.Site had not received sample.Batch f26176 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (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).Consumer reports "blisters developed while wearing wrap." the cause of the consumer developing "blisters" is inconclusive.The review of records does not provide evidence to support the 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 and release testing data.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the subclass adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Follow-up (17mar2020): new information reported from a contactable consumer includes: additional reporter added.Follow-up (27apr2020): new information received from product quality complaint group includes investigation results.
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Manufacturer Narrative
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Batch f26176 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (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).Consumer reports "blisters developed while wearing wrap." the cause of the consumer developing "blisters¿ is inconclusive.The review of records does not provide evidence to support the 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 and release testing data.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the subclass adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.
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Event Description
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Event verbatim [preferred term] read the usage instructions/did not check her skin under the product while wearing thermacare/she attached the adhesive to: body [intentional device misuse], used expired wrap [expired device used], three blisters on back/felt something really hot while using wrap/one spot was still burning her pretty bad/hurting really bad [burns second degree], , narrative: this is a spontaneous report from two contactable consumers (one was patient).An 89-year-old non-pregnant female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number f26176, expiration date apr2014, udi#: (b)(4) , via an unspecified route of administration on (b)(6) 2020 (reported as "(b)(6) 2020", pending clarification) applied to lower back for 6 hours for backache.Medical history included stroke (2 strokes since the end of 2017), macular degeneration from 2016 and ongoing, rheumatoid arthritis (since age 17), ongoing psoriatic arthritis, hysterectomy (since age 28), neuropathy, poor circulation, neck pain and ongoing post-menopausal.The patient was currently under the care of a physician for ongoing high blood pressure and she saw a heart and arthritis specialists, went to the retina clinic because she was going blind with macular degeneration.The patient classified her skin tone as very light or fair.She didn't have sensitive skin but she had the abnormal skin conditions provided as atopic dermatitis skin allergy.The patient also added that she had psoriasis and she always looked like she was broken out with the measles.She was not sure if it is the measles.She had brown old age spots that looked like measles.Her doctor had ignored this.Concomitant medication included camphor/eucalyptus globulus oil/juniperus virginiana wood oil/menthol/myristica fragrans oil/pinus nigra oil/thymol (vick vapour-rub) on her arms and legs for psoriasis.The patient was also taking other medications which she said her medication list was a mile long and she didn't mess with them or know the stuff that was in them and her daughter took care of her medications.The patient had previously used thermacare heatwraps for a long time but not experienced the same problem.The patient had previously used other heat products for pain relief, clarifying she used a couple of months ago for neck pain and hadn't experienced a problem.The patient stated she had a backache yesterday (b)(6) 2020) and applied a wrap.Suddenly she felt something really hot on (b)(6) 2020.She couldn't see but it hurt.She stated the very bottom of wrap had gotten wet at the very tip from her diaper or pad.It bothered through the night.Today on (b)(6) 2020 she had her neighbor come check her back and she had 3 blisters, clarifying one looked really bad and was opened.Her neighbor applied aloe vera from a plant on the blister.The patient stated she was trying to get up with doctor.It would take a while to get through to the doctor.She couldn't drive and would have to have someone take her to the doctor's office.She was hurting really bad and felt a big bump then she had stuff on her hands.The patient stated she had used thermacare heatwraps for a long time and had never had this happen before.She stated the wraps were on sale.She bought a lot because she was using so many and wanted to have them.She didn't expect this to happen.The patient realized the expiry was apr2014 and she used the expired wipe on (b)(6) 2020, asking what happened if one used the wraps after expiry.The patient stated the blisters were close to her spine.She said one spot was still burning her pretty bad.The aloe vera should take the burn out.She said one blister was the size of a quarter to a fifty cent piece and the other two were the size of nickels.The patient stated while she was wearing thermacare, she attached the adhesive to body for 6 hours.The patient did not engage in exercise while using the product.The patient did not check her skin under the product while wearing thermacare and she read the usage instructions on thermacare before she used the product.There was no product remaining as the patient had discarded the product.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event "three blisters on back/felt something really hot while using wrap/one spot was still burning her pretty bad/hurting really bad" was not recovered, of the other events was unknown.According to product quality complaint group: severity of harm is s3.Site had not received sample.Batch f26176 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (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).Consumer reports "blisters developed while wearing wrap." the cause of the consumer developing "blisters" is inconclusive.The review of records does not provide evidence to support the 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 and release testing data.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the subclass adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.On (b)(6) 2020, the product quality complaint group provided the following updated investigation results for product thermacare lower back & hip, lot number and expiration date f26176 and apr2014, description of compliant "blisters developed while wearing wrap", complaint sub-class "adverse event/serious/unknown", that still yielded no product quality issues.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Summary of investigation: batch f26176 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (dhr) and trending were evaluated.No quality issues were identified.Batch/process record review: review of the batch device history record for this batch concludes all release requirements were met.Lot trend assessment.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass adverse event/serious/unknown received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend identified?: no.Expedited trend actions taken: based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment adverse event serious unknown lbh (b)(6) 2017 to (b)(6) 2020.There was deviation from sop, complaint trending guidelines, effective (b)(6) 2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).Consumer reports "blisters developed while wearing wrap." the cause of the consumer developing "blisters" is inconclusive.The review of records does not provide evidence to support the 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 and release testing data.The product at the time this investigation was written has expired.Expiry date was apr2014.The product quality for the batch is not impacted by this complaint.Follow-up (17mar2020): new information reported from a contactable consumer includes: additional reporter added.Follow-up (27apr2020): new information received from product quality complaint group includes investigation results.Amendment: this follow-up report is being submitted to amend previously reported information: the event 'read the usage instructions/applied a wrap for backache' was deleted.Follow-up (15may2020): follow-up attempts completed.No further information is expected.Follow-up (13oct2020): new information received from the product quality complaint group included: updated investigation results that still yielded no product quality issues.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Product: thermacare lower back & hip.Lot number and expiration date: f26176 and apr2014.Description of compliant: "blisters developed while wearing wrap".Complaint sub-class: "adverse event/serious/unknown".Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Summary of investigation: batch f26176 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (dhr) and trending were evaluated.No quality issues were identified.Batch/process record review: review of the batch device history record for this batch concludes all release requirements were met.Lot trend assessment.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass adverse event/serious/unknown received at the site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend identified?: no.Expedited trend actions taken: based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment adverse event serious unknown lbh 11mar2017 to 11mar2020.There was deviation from sop, complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).Consumer reports "blisters developed while wearing wrap." the cause of the consumer developing "blisters" is inconclusive.The review of records does not provide evidence to support the 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 and release testing data.The product at the time this investigation was written has expired.Expiry date was apr2014.The product quality for the batch is not impacted by this complaint.
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Search Alerts/Recalls
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