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PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT
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| Lot Number L44153 |
| Device Problem
Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Burn(s) (1757); Purulent Discharge (1812); Unspecified Infection (1930); Rash (2033)
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| Event Date 09/18/2016 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] burn marks with blisters [burns second degree] , did not check the skin under the wrap during product use [intentional device misuse] , the black means it is turning into dead skin, and that means infection [wound infection] , pus stains on his shirt [purulent discharge] , felt the heatwrap was getting too hot [product quality issue] , burn marks, they are darkening, one of the three is black [skin discolouration] , some of the blisters had popped [blister rupture] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) male patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: l44153, expiration date: may2018) from (b)(6) 2016 for tense muscles.Medical history included sleep apnea syndrome from an unknown date and unknown if ongoing, sleeplessness from an unknown date and unknown if ongoing and back pain from an unknown date and unknown if ongoing.The patient denied the following medical conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on their skin, rheumatoid arthritis, decreased sensation and neuropathy.Concomitant medication included ongoing cyclobenzaprine hydrochloride (flexeril) from an unspecified date at an unspecified dose for tense muscles, temazepam (restoril) from an unspecified date at an unspecified dose as a sleep aide and naproxen sodium (aleve) from an unspecified date at an unspecified dose for his back bugging him.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported he took an (b)(6) as his back was bugging him.Later that day, he applied a heatwrap for 1.5-2 hours and he felt like it was getting too hot.He stated he experienced burn marks and blisters that were like golf ball sizes after using the thermacare heatwraps on top of one of his shirts (not applied directly to the skin).He mentioned he did not check the skin under the wrap while using the heatwrap.The patient reported one of the blisters must have popped.He stated his wife lifted up his shirt and he had 12 little circular-like dots on his mid-back and 5 of them were like if they were to cut a golf ball in half that were like blisters.Some of the blisters had popped and there were pus stains on his shirt.Some spots have improved but he stated he has worsened as now there is a black area.The patient stated he used to be a firefighter and used an over the counter burn remedy that he had in his medical bag as a treatment that was recommended by his pharmacist.The pharmacist told him it would be the best thing for it.He did not know the name of the burn remedy and he did not currently have the bag with him.It was an aloe based cooling ointment.He only used it one time which was yesterday (b)(6) 2016.The patient stated about 90% of the blisters are gone, but there are still 3 blisters remaining in his mid-back that look like infection because they are darkening.One of the three is black.The patient stated "the black means it is turning into dead skin, and that means infection." the patient denied consulting a healthcare professional for the events.The patient assessed his skin tone as fair.He denied having sensitive skin or any abnormal skin conditions (only has a some moles).The patient previously used other heat products for pain relief such as heating pads and blubbers you put in the microwave.He did not engage in exercise while using the product and did read the usage instructions on the wrap before using the product.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included an unspecified over the counter burn remedy, elaborated as an aloe based cooling ointment.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the events of second degree burn, wound infection, purulent discharge, blisters popped, skin darkened, felt the heatwrap was getting too hot, and used heatwrap without checking the skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Comment: based on the information provided, the events of second degree burn, wound infection, purulent discharge, blisters popped, skin darkened, felt the heatwrap was getting too hot, and used heatwrap without checking the skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The returned consumer sample did not provide any additional information to determine a root cause of the alleged wrap causing a burn.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Event Description
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Event verbatim [preferred term] burn marks with blisters [burns second degree] , did not check the skin under the wrap during product use [intentional device misuse] , the black means it is turning into dead skin, and that means infection [wound infection] , pus stains on his shirt [purulent discharge] , felt the heatwrap was getting too hot [product quality issue] , burn marks, they are darkening, one of the three is black [skin discolouration] , some of the blisters had popped [blister rupture] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) male patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: l44153, expiration date: may2018) from (b)(6) 2016 for tense muscles.Medical history included sleep apnea syndrome from an unknown date and unknown if ongoing, sleeplessness from an unknown date and unknown if ongoing and back pain from an unknown date and unknown if ongoing.The patient denied the following medical conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on their skin, rheumatoid arthritis, decreased sensation and neuropathy.Concomitant medication included ongoing cyclobenzaprine hydrochloride (flexeril) from an unspecified date at an unspecified dose for tense muscles, temazepam (restoril) from an unspecified date at an unspecified dose as a sleep aide and naproxen sodium (aleve) from an unspecified date at an unspecified dose for his back bugging him.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported he took an aleve as his back was bugging him.Later that day, he applied a heatwrap for 1.5-2 hours and he felt like it was getting too hot.He stated he experienced burn marks and blisters that were like golf ball sizes after using the thermacare heatwraps on top of one of his shirts (not applied directly to the skin).He mentioned he did not check the skin under the wrap while using the heatwrap.The patient reported one of the blisters must have popped.He stated his wife lifted up his shirt and he had 12 little circular-like dots on his mid-back and 5 of them were like if they were to cut a golf ball in half that were like blisters.Some of the blisters had popped and there were pus stains on his shirt.Some spots have improved but he stated he has worsened as now there is a black area.The patient stated he used to be a firefighter and used an over the counter burn remedy that he had in his medical bag as a treatment that was recommended by his pharmacist.The pharmacist told him it would be the best thing for it.He did not know the name of the burn remedy and he did not currently have the bag with him.It was an aloe based cooling ointment.He only used it one time which was yesterday (b)(6) 2016.The patient stated about 90% of the blisters are gone, but there are still 3 blisters remaining in his mid-back that look like infection because they are darkening.One of the three is black.The patient stated "the black means it is turning into dead skin, and that means infection." the patient denied consulting a healthcare professional for the events.The patient assessed his skin tone as fair.He denied having sensitive skin or any abnormal skin conditions (only has a some moles).The patient previously used other heat products for pain relief such as heating pads and blubbers you put in the microwave.He did not engage in exercise while using the product and did read the usage instructions on the wrap before using the product.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included an unspecified over the counter burn remedy, elaborated as an aloe based cooling ointment.Clinical outcome of the events was not resolved.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The returned consumer sample did not provide any additional information to determine a root cause of the alleged wrap causing a burn.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow up (09nov2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment based on the information provided, the events of second degree burn, wound infection, purulent discharge, blisters popped, skin darkened, felt the heatwrap was getting too hot, and used heatwrap without checking the skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability., comment: based on the information provided, the events of second degree burn, wound infection, purulent discharge, blisters popped, skin darkened, felt the heatwrap was getting too hot, and used heatwrap without checking the skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The returned consumer sample did not provide any additional information to determine a root cause of the alleged wrap causing a burn.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Event Description
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Burn marks with blisters [burns second degree] , did not check the skin under the wrap during product use [intentional device misuse] , did not check the skin under the wrap during product use [device use error] , the black means it is turning into dead skin, and that means infection [wound infection] , pus stains on his shirt [purulent discharge] , felt the heatwrap was getting too hot [product quality issue] , burn marks, they are darkening, one of the three is black [skin discolouration] , some of the blisters had popped [blister rupture] , scars for life [scar] , still have redness and irritation [erythema] , still have redness and irritable still [skin irritation] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) caucasian male patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: l44153, expiration date: may2018) from (b)(6) 2016 (previously reported as (b)(6) 2016) for tense muscles and back pain t8 t9 vertebra.Medical history included sleep apnea syndrome from an unknown date and unknown if ongoing, sleeplessness from an unknown date and unknown if ongoing and back pain from an unknown date and unknown if ongoing.The patient denied the following medical conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on their skin, rheumatoid arthritis, decreased sensation and neuropathy.Concomitant medication included ongoing cyclobenzaprine hydrochloride (flexeril) from an unspecified date at an unspecified dose for tense muscles and back pain, temazepam (restoril) from an unspecified date at an unspecified dose as a sleep aide and naproxen sodium (aleve) from an unspecified date at an unspecified dose for his back bugging him (back pain) and shoulder pain.Past product history included thermacare heatwraps (thermacare heatwraps) from (b)(6) 2014 for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported he took an aleve as his back was bugging him.Later that day, he applied a heatwrap for 1.5-2 hours and he felt like it was getting too hot.He reported he used the heatwrap for one day for three hours.He reported he attached the adhesive to: body; clothing; but heat elements were on cotton.He stated he experienced burn marks and blisters that were like golf ball sizes after using the thermacare heatwraps on top of one of his shirts (not applied directly to the skin).Upon follow up it was reported he was hospitalized for the events blister, burn marks and the black means it is turning into dead skin, that means infection.He mentioned he did not check the skin under the wrap while using the heatwrap.The patient reported one of the blisters must have popped.He stated his wife lifted up his shirt and he had 12 little circular-like dots on his mid-back and 5 of them were like if they were to cut a golf ball in half that were like blisters.Some of the blisters had popped and there were pus stains on his shirt.Some spots have improved but he stated he has worsened as now there is a black area.The patient stated he used to be a firefighter and used an over the counter burn remedy that he had in his medical bag as a treatment that was recommended by his pharmacist.The pharmacist told him it would be the best thing for it.He did not know the name of the burn remedy and he did not currently have the bag with him.It was an aloe based cooling ointment.He only used it one time which was yesterday (b)(6) 2016.It was also reported he was treated with "4 egg stare".The patient stated about 90% of the blisters are gone, but there are still 3 blisters remaining in his mid-back that look like infection because they are darkening.One of the three is black.The patient stated "the black means it is turning into dead skin, and that means infection." upon follow up he reported he still had redness and irritation and scars for life.He consulted a physician at urgent care.The patient assessed his skin tone as medium.He denied having sensitive skin or any abnormal skin conditions (only has a some moles).The patient previously used other heat products for pain relief such as heating pads and blubbers you put in the microwave.He did not engage in exercise while using the product and did read the usage instructions on the wrap before using the product.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included an unspecified over the counter burn remedy, elaborated as an aloe based cooling ointment.Clinical outcome of the events was not resolved.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The returned consumer sample did not provide any additional information to determine a root cause of the alleged wrap causing a burn.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow up (09nov2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (16nov2016): follow-up attempts are completed.No further information is expected.Amendment: this followup is being submitted to amend previously reported information: the event term wrong technique in device usage process was added.Additional information received on 18nov2016 from a contactable consumer included concomitant medication indications, product data (additional indication, duration of use), reaction data (additional events of redness, irritation, and scar, seriousness criteria of hospitalization for the events blister, burn marks and the black means it is turning into dead skin, that means infection and additional treatment).Company clinical evaluation comment based on the information provided, the events of second degree burn, wound infection, purulent discharge, blisters popped, skin darkened, scar, felt the heat wrap was getting too hot, and used heat wrap without checking the skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events skin irritation and erythema as assessed as associated with the device use.No device malfunction has been identified., comment: based on the information provided, the events of second degree burn, wound infection, purulent discharge, blisters popped, skin darkened, scar, felt the heat wrap was getting too hot, and used heat wrap without checking the skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events skin irritation and erythema as assessed as associated with the device use.No device malfunction has been identified.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The returned consumer sample did not provide any additional information to determine a root cause of the alleged wrap causing a burn.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Event Description
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Event verbatim [preferred term] burn marks with blisters [burns second degree], did not check the skin under the wrap during product use [intentional device misuse], did not check the skin under the wrap during product use [device use error] , the black means it is turning into dead skin, and that means infection [wound infection], pus stains on his shirt [purulent discharge], felt the heatwrap was getting too hot [product quality issue], burn marks, they are darkening, one of the three is black [skin discolouration], some of the blisters had popped [blister rupture], scars for life [scar], still have redness and irritation [erythema], still have reddness and irritable still [skin irritation].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) caucasian male patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: l44153, expiration date: may2018) from (b)(6) 2016 (previously reported as (b)(6) 2016) for tense muscles and back pain t8 t9 vertebra.Medical history included sleep apnea syndrome from an unknown date and unknown if ongoing, sleeplessness from an unknown date and unknown if ongoing and back pain from an unknown date and unknown if ongoing.The patient denied the following medical conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on their skin, rheumatoid arthritis, decreased sensation and neuropathy.Concomitant medication included ongoing cyclobenzaprine hydrochloride (flexeril) from an unspecified date at an unspecified dose for tense muscles and back pain, temazepam (restoril) from an unspecified date at an unspecified dose as a sleep aide and naproxen sodium (aleve) from an unspecified date at an unspecified dose for his back bugging him (back pain) and shoulder pain.Past product history included thermacare heatwraps (thermacare heatwraps) from (b)(6) 2014 for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported he took an aleve as his back was bugging him.Later that day, he applied a heatwrap for 1.5-2 hours and he felt like it was getting too hot.He reported he used the heatwrap for one day for three hours.He reported he attached the adhesive to: body; clothing; but heat elements were on cotton.He stated he experienced burn marks and blisters that were like golf ball sizes after using the thermacare heatwraps on top of one of his shirts (not applied directly to the skin).Upon follow up it was reported he was hospitalized for the events blister, burn marks and the black means it is turning into dead skin, that means infection.He mentioned he did not check the skin under the wrap while using the heatwrap.The patient reported one of the blisters must have popped.He stated his wife lifted up his shirt and he had 12 little circular-like dots on his mid-back and 5 of them were like if they were to cut a golf ball in half that were like blisters.Some of the blisters had popped and there were pus stains on his shirt.Some spots have improved but he stated he has worsened as now there is a black area.The patient stated he used to be a firefighter and used an over the counter burn remedy that he had in his medical bag as a treatment that was recommended by his pharmacist.The pharmacist told him it would be the best thing for it.He did not know the name of the burn remedy and he did not currently have the bag with him.It was an aloe based cooling ointment.He only used it one time which was yesterday (b)(6) 2016.It was also reported he was treated with "4 egg stare".The patient stated about 90% of the blisters are gone, but there are still 3 blisters remaining in his mid-back that look like infection because they are darkening.One of the three is black.The patient stated "the black means it is turning into dead skin, and that means infection." upon follow up he reported he still had redness and irritation and scars for life.He consulted a physician at urgent care.The patient assessed his skin tone as medium.He denied having sensitive skin or any abnormal skin conditions (only has a some moles).The patient previously used other heat products for pain relief such as heating pads and blubbers you put in the microwave.He did not engage in exercise while using the product and did read the usage instructions on the wrap before using the product.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included an unspecified over the counter burn remedy, elaborated as an aloe based cooling ointment.Clinical outcome of the events was not resolved.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The returned consumer sample did not provide any additional information to determine a root cause of the alleged wrap causing a burn.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow up (09nov2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (16nov2016): follow-up attempts are completed.No further information is expected.Amendment: this followup is being submitted to amend previously reported information: the event term wrong technique in device usage process was added.Additional information received on 18nov2016 from a contactable consumer included concomitant medication indications, product data (additional indication, duration of use), reaction data (additional events of redness, irritation, and scar, seriousness criteria of hospitalization for the events blister, burn marks and the black means it is turning into dead skin, that means infection and additional treatment).Company clinical evaluation comment: based on the information provided, the events of second degree burn, wound infection, purulent discharge, blisters popped, skin darkened, scar, felt the heat wrap was getting too hot, and used heat wrap without checking the skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events skin irritation and erythema as assessed as associated with the device use.No device malfunction has been identified.Amendment: this follow up is being submitted to amend previously reported information: the start date for past product use of thermacare heatwrap was updated to (b)(6) 2014., comment: based on the information provided, the events of second degree burn, wound infection, purulent discharge, blisters popped, skin darkened, scar, felt the heat wrap was getting too hot, and used heat wrap without checking the skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events skin irritation and erythema as assessed as associated with the device use.No device malfunction has been identified.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The returned consumer sample did not provide any additional information to determine a root cause of the alleged wrap causing a burn.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Event Description
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Event verbatim [preferred term] third degree burns [burns third degree] , burn marks with blisters / burning on back [burns second degree] , the black means it is turning into dead skin, and that means infection [wound infection] , did not check the skin under the wrap during product use [intentional device misuse] , did not check the skin under the wrap during product use [device use error] , pus stains on his shirt [purulent discharge] , felt the heatwrap was getting too hot [product quality issue] , burn marks, they are darkening, one of the three is black [skin discolouration] , some of the blisters had popped [blister rupture] , scars for life/scars on back [scar] , still have redness and irritation [erythema] , still have redness and irritable still [skin irritation] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) -year-old caucasian male patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: l44153, expiration date: (b)(6) 2018) from (b)(6) 2016 (previously reported as (b)(6) 2016) for tense muscles, sore muscles and back pain t8 t9 vertebra.Medical history included sleep apnea syndrome from an unknown date and unknown if ongoing, sleeplessness from an unknown date and unknown if ongoing and back pain from an unknown date and unknown if ongoing.The patient denied the following medical conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on their skin, rheumatoid arthritis, decreased sensation and neuropathy.Concomitant medication included ongoing cyclobenzaprine hydrochloride (flexeril) from an unspecified date at an unspecified dose for tense muscles and back pain, temazepam (restoril) from an unspecified date at an unspecified dose as a sleep aide and naproxen sodium (aleve) from an unspecified date at an unspecified dose for his back bugging him (back pain) and shoulder pain.Past product history included thermacare heatwraps (thermacare heatwraps) from (b)(6) 2014 for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported he took an aleve as his back was bugging him.Later that day, he applied a heatwrap for 1.5-2 hours and he felt like it was getting too hot.He reported he used the heatwrap for one day for three hours.He reported he attached the adhesive to: body; clothing; but heat elements were on cotton.He stated he experienced burn marks, burning on back and blisters that were like golf ball sizes after using the thermacare heatwraps on top of one of his shirts (not applied directly to the skin).Upon follow up it was reported he was hospitalized for the events blister, burn marks and the black means it is turning into dead skin, that means infection.He mentioned he did not check the skin under the wrap while using the heatwrap.The patient reported one of the blisters must have popped.He stated his wife lifted up his shirt and he had 12 little circular-like dots on his mid-back and 5 of them were like if they were to cut a golf ball in half that were like blisters.Some of the blisters had popped and there were pus stains on his shirt.Some spots have improved but he stated he has worsened as now there is a black area.The patient stated he used to be a firefighter and used an over the counter burn remedy that he had in his medical bag as a treatment that was recommended by his pharmacist.The pharmacist told him it would be the best thing for it.He did not know the name of the burn remedy and he did not currently have the bag with him.It was an aloe based cooling ointment.He only used it one time which was yesterday (b)(6) 2016.It was also reported he was treated with "4 egg stare".The patient stated about 90% of the blisters are gone, but there are still 3 blisters remaining in his mid-back that look like infection because they are darkening.One of the three is black.The patient stated "the black means it is turning into dead skin, and that means infection." upon follow up he reported he still had redness and irritation and scars for life.He consulted a physician at urgent care.Upon follow up received (b)(6) 2017, the patient reported he experienced third degree burns on an unspecified date.The patient assessed his skin tone as medium.He denied having sensitive skin or any abnormal skin conditions (only has a some moles).The patient previously used other heat products for pain relief such as heating pads and blubbers you put in the microwave.He did not engage in exercise while using the product and did read the usage instructions on the wrap before using the product.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included an unspecified over the counter burn remedy, elaborated as an aloe based cooling ointment.Clinical outcome of the events was not resolved.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The returned consumer sample did not provide any additional information to determine a root cause of the alleged wrap causing a burn.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow up ((b)(6) 2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up ((b)(6) 2016): follow-up attempts are completed.No further information is expected.Amendment: this follow up is being submitted to amend previously reported information: the event term wrong technique in device usage process was added.Additional information received on (b)(6) 2016 from a contactable consumer included concomitant medication indications, product data (additional indication, duration of use), reaction data (additional events of redness, irritation, and scar, seriousness criteria of hospitalization for the events blister, burn marks and the black means it is turning into dead skin, that means infection and additional treatment).Amendment: this follow up is being submitted to amend previously reported information: the start date for past product use of thermacare heatwrap was updated to (b)(6) 2014.Follow-up ((b)(6) 2017): new information received from a contactable consumer included product data (additional indication of product) and reaction data (additional event of third degree burn and event description burning on back).Company clinical evaluation comment.Based on the information provided, the events of burn third degree, second degree burn, wound infection, purulent discharge, blisters popped, skin darkened, scar, felt the heat wrap was getting too hot, and used heat wrap without checking the skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events skin irritation and erythema as assessed as associated with the device use.No device malfunction has been identified., comment: based on the information provided, the events of burn third degree, second degree burn, wound infection, purulent discharge, blisters popped, skin darkened, scar, felt the heat wrap was getting too hot, and used heat wrap without checking the skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events skin irritation and erythema as assessed as associated with the device use.No device malfunction has been identified.
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