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| Lot Number L-70230 |
| Device Problem
Temperature Problem (3022)
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| Patient Problems
Burn(s) (1757); Pain (1994)
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| Event Date 03/01/2016 |
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Event Type
Injury
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Event Description
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Burnt her back it had little pink spots on her back/feel the pain [thermal burn].Looked like her skin had been taken off [skin exfoliation].Case description: this is a spontaneous report from a contactable consumer.A (b)(6)-years-old black female patient started to receive thermacare heatwrap (thermacare lower back & hip), from (b)(6) 2016 for back pain.Medical history included pain from an unknown date and used electric heating pad in (b)(6) 2016 for a couple of days, for an hour at a time.There were no concomitant medications.The patient previously took thermacare heatwraps menstrual products on for 8 hours, never had a burn and never had a problem.The patient had the product on for 4 hours on (b)(6) 2016, and afterwards, about an hour and a half later, she felt like a sting and could not rub across it.If clothing touched it, she could feel the pain, and that is what made her go look.She saw little pink spots on her lower back, in the area of her tattoo and around it.It looked like her skin had been taken off, it had little pink spots on her back.She has been rubbing vaseline on the burn.The burn was trying to heal up.The action taken of the product was permanent withdrawn on (b)(6) 2016.The outcome of the event was recovering.The patient classified skin tone is medium/dark, no sensitive skin, no abnormal skin conditions, she did not sleep while wearing the product, not wearing several layers of clothing over the thermacare product, no wearing a snug waistband/belt or similar or otherwise applied pressure over the area, attached the adhesive to body, not engage in exercise while using the product, checked skin under the product while wearing thermacare, she took it off for a few minutes to check and readjusted it and put it back and she did this about 3 times over 4 hours.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 'burnt her back, looked like her skin had been taken off, it had little pink spots on her back, feel the pain' 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 (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events of 'burnt her back, looked like her skin had been taken off, it had little pink spots on her back, feel the pain' 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 (b)(6) and 30-day fda reportability.
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Event Description
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Looked like her skin had been taken off/little pinkish no skin on those spots [skin exfoliation].Burnt her back it had little pink spots on her back/feel the pain/first degree burn [burns first degree].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) black female patient started to receive thermacare heatwrap (thermacare lower back & hip), from (b)(6) 2016 for back pain.Medical history included pain from an unknown date and used electric heating pad in (b)(6) 2016 for a couple of days, for an hour at a time.There were no concomitant medications.The patient previously took thermacare heatwraps menstrual products on for 8 hours, never had a burn and never had a problem.The patient had the product on for 4 hours on (b)(6) 2016, and afterwards, about an hour and a half later, she felt like a sting and could not rub across it.If clothing touched it, she could feel the pain, and that is what made her go look.She saw little pink spots on her lower back, in the area of her tattoo and around it.It looked like her skin had been taken off, it had little pink spots on her back.She has been rubbing vaseline on the burn.The burn was trying to heal up.The action taken of the product was permanent withdrawn on (b)(6) 2016.The outcome of the event was recovering.The patient classified skin tone is medium/dark, no sensitive skin, no abnormal skin conditions, she did not sleep while wearing the product, not wearing several layers of clothing over the thermacare product, no wearing a snug waistband/belt or similar or otherwise applied pressure over the area, attached the adhesive to body, not engage in exercise while using the product, checked skin under the product while wearing thermacare, she took it off for a few minutes to check and readjusted it and put it back and she did this about 3 times over 4 hours.Additional information has been requested and will be provided as it becomes available.Follow-up (13jun2016): this contactable attorney reported by way of medical records and consumer questionnaire.This female patient applied thermacare heatwrap (thermacare lower back & hip) large to extra large (l-xl) for lower back pain.It was reported that, the lot number was l-70230, expiration date was feb2018 and ndc code was 0573301001.Her social history included alcohol use (wine and liquor) 2-4 per week on an unknown date.Her family history included diabetes (father) and hypertension (father and mother) on an unknown date.Her past drug history included thermacare menstrual heating pad several times and never had an issue and it was placed directly on her skin.On the day after application of product, she had discomfort pain in her lower back and the skin was burnt in different spots and was diagnosed with first degree burn.It was reported that, her skin was little pinkish and no skin on those spots.She had rash and it was described as blistering, itching, tender but not red, scaling, spreading, warm to touch, weeping and ulcerated.It was reported that, she was still experiencing burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off.She was hospitalized on an unknown date for looked like her skin had been taken off.On an unknown date, she was treated with unknown over the counter (otc) creams to apply on her skin and pain has getting better.She was received an unknown treatment for burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off.As of (b)(6) 2016, the clinical outcome of the events burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off was not recovered.
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Event Description
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Looked like her skin had been taken off/little pinkish no skin on those spots [skin exfoliation].Second degree burn [burns second degree].Burnt her back it had little pink spots on her back/feel the pain/first degree burn [burns first degree].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back and hip), from (b)(6) 2016 for back pain.Medical history included pain from an unknown date and used electric heating pad in (b)(6) 2016 for a couple of days, for an hour at a time.There were no concomitant medications.The patient previously took thermacare heatwraps menstrual products on for 8 hours, never had a burn and never had a problem.The patient had the product on for 4 hours on (b)(6) 2016, and afterwards, about an hour and a half later, she felt like a sting and could not rub across it.If clothing touched it, she could feel the pain, and that is what made her go look.She saw little pink spots on her lower back, in the area of her tattoo and around it.It looked like her skin had been taken off, it had little pink spots on her back.She has been rubbing vaseline on the burn.The burn was trying to heal up.The action taken of the product was permanent withdrawn on (b)(6) 2016.The outcome of the event was recovering.The patient classified skin tone is medium/dark, no sensitive skin, no abnormal skin conditions, she did not sleep while wearing the product, not wearing several layers of clothing over the thermacare product, no wearing a snug waistband/belt or similar or otherwise applied pressure over the area, attached the adhesive to body, not engage in exercise while using the product, checked skin under the product while wearing thermacare, she took it off for a few minutes to check and readjusted it and put it back and she did this about 3 times over 4 hours.Additional information has been requested and will be provided as it becomes available.Follow-up (13jun2016): this contactable attorney reported by way of medical records and consumer questionnaire.This female patient applied thermacare heatwrap (thermacare lower back and hip) large to extra large (l-xl) for lower back pain.It was reported that, the lot number was l-70230, expiration date was feb2018 and ndc code was (b)(6).Her social history included alcohol use (wine and liquor) 2-4 per week on an unknown date.Her family history included diabetes (father) and hypertension (father and mother) on an unknown date.Her past drug history included thermacare menstrual heating pad several times and never had an issue and it was placed directly on her skin.On the day after application of product, she had discomfort pain in her lower back and the skin was burnt in different spots and was diagnosed with first degree burn.It was reported that, her skin was little pinkish and no skin on those spots.She had rash and it was described as blistering, itching, tender but not red, scaling, spreading, warm to touch, weeping and ulcerated.It was reported that, she was still experiencing burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off.She was hospitalized on an unknown date for looked like her skin had been taken off.On an unknown date, she was treated with unknown over the counter (otc) creams to apply on her skin and pain has getting better.She was received an unknown treatment for burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off.As of 13jun2016, the clinical outcome of the events burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off was not recovered.Follow-up (28jun2016): this contactable attorney reported by way of consumer questionnaire.This female patient purchased thermacare heatwrap (thermacare lower back and hip) from (b)(6) in (b)(6) 2016 and applied only for one day in (b)(6) 2016 on her lower back.She left the product 1-2 hours on at one time during the course of 24 hours.It was stated that the skin was damaged or broken prior to usage, but did not experienced bruised or swelled 48 hours prior to usage of product.She placed the product over her clothing and did not detect irritation, redness or burning during usage.In (b)(6) 2016, she experienced uncomfortable feeling on the back and burning sensation in different area.On the same day, she was diagnosed with second degree burn.She was prescribed with a topical cream and referred to a dermatologist.The dermatologist provided a higher grade topical cream and she applied daily.As of 28jun2016, the clinical outcome of the event second degree burn was unknown.
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Manufacturer Narrative
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Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The 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.Other trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage (citi) search was performed.Scope: date contacted: (b)(6) 2013 through (b)(6) 2016/ manufacturing site: pfizer albany/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation the citi search returned a total (b)(4) complaint for the lower back and hip (lbh) products during this time period for the class/subclass adverse event safety request for investigation.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.A citi complaint trend search was conducted for the subclass adverse event safety request for investigation for lbh 8 hr products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh 8hr products, refer to the attached trend chart for (b)(6) 2013 - (b)(6) 2016.There is no further action required.
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Event Description
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Event verbatim [preferred term] looked like her skin had been taken off/little pinkish no skin on those spots [skin exfoliation] , burnt her back it had little pink spots on her back/feel the pain/first degree burn [burns first degree] , second degree burn [burns second degree], case narrative:this is a spontaneous report from a contactable consumer.A 34-years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), from (b)(6) 2016 for back pain.Medical history included pain from an unknown date and used electric heating pad in (b)(6) 2016 for a couple of days, for an hour at a time.There were no concomitant medications.The patient previously took thermacare heatwraps menstrual products on for 8 hours, never had a burn and never had a problem.The patient had the product on for 4 hours on (b)(6) 2016, and afterwards, about an hour and a half later, she felt like a sting and could not rub across it.If clothing touched it, she could feel the pain, and that is what made her go look.She saw little pink spots on her lower back, in the area of her tattoo and around it.It looked like her skin had been taken off, it had little pink spots on her back.She has been rubbing vaseline on the burn.The burn was trying to heal up.The action taken of the product was permanent withdrawn on (b)(6) 2016.The outcome of the event was recovering.The patient classified skin tone is medium/dark, no sensitive skin, no abnormal skin conditions, she did not sleep while wearing the product, not wearing several layers of clothing over the thermacare product, no wearing a snug waistband/belt or similar or otherwise applied pressure over the area, attached the adhesive to body, not engage in exercise while using the product, checked skin under the product while wearing thermacare, she took it off for a few minutes to check and readjusted it and put it back and she did this about 3 times over 4 hours.Follow-up ((b)(6) 2016): this contactable consumer reported in consumer's claim by way of medical records and consumer questionnaire.This female patient applied thermacare heatwrap (thermacare lower back & hip) large to extra large (l-xl) for lower back pain.It was reported that, the lot number was l-70230, expiration date was (b)(6) 2018 and ndc code was 0573301001.Her social history included alcohol use (wine and liquor) 2-4 per week on an unknown date.Her family history included diabetes (father) and hypertension (father and mother) on an unknown date.Her past drug history included thermacare menstrual heating pad several times and never had an issue and it was placed directly on her skin.On the day after application of product, she had discomfort pain in her lower back and the skin was burnt in different spots and was diagnosed with first degree burn.It was reported that, her skin was little pinkish and no skin on those spots.She had rash and it was described as blistering, itching, tender but not red, scaling, spreading, warm to touch, weeping and ulcerated.It was reported that, she was still experiencing burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off.She was hospitalized on an unknown date for looked like her skin had been taken off.On an unknown date, she was treated with unknown over the counter (otc) creams to apply on her skin and pain has getting better.She was received an unknown treatment for burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off.As of (b)(6) 2016, the clinical outcome of the events burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off was not recovered.Follow-up ((b)(6) 2016): this contactable consumer reported in consumer's claim by way of consumer questionnaire.This female patient purchased thermacare heatwrap (thermacare lower back & hip) from wal-mart in (b)(6) 2016 and applied only for one day in (b)(6) 2016 on her lower back.She left the product 1-2 hours on at one time during the course of 24 hours.It was stated that the skin was damaged or broken prior to usage, but did not experienced bruised or swelled 48 hours prior to usage of product.She placed the product over her clothing and did not detect irritation, redness or burning during usage.In (b)(6) 2016, she experienced uncomfortable feeling on the back and burning sensation in different area.On the same day, she was diagnosed with second degree burn.She was prescribed with a topical cream and referred to a dermatologist.The dermatologist provided a higher grade topical cream and she applied daily.As of (b)(6) 2016, the clinical outcome of the event second degree burn was unknown.Follow-up ((b)(6) 2019): this is a follow-up report from product quality complaint group included: the reporter's occupation was corrected from attorney to consumer.Follow-up (27oct2019): this is a follow-up report from product quality complaint group included: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The 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.Other trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage (citi) search was performed.Scope: date contacted: (b)(6) 2013 through (b)(6) 2016/ manufacturing site: pfizer albany/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation the citi search returned a total (b)(4) complaint for the lower back and hip (lbh) products during this time period for the class/subclass adverse event safety request for investigation.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.A citi complaint trend search was conducted for the subclass adverse event safety request for investigation for lbh 8 hr products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh 8hr products, refer to the attached trend chart for (b)(6) 2013 - (b)(6) 2016.There is no further action required.
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Event Description
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Looked like her skin had been taken off/little pinkish no skin on those spots [skin exfoliation], burnt her back it had little pink spots on her back/feel the pain/first degree burn [burns first degree], second degree burn [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.A 34-years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), from on (b)(6) 2016 for back pain.Medical history included pain from an unknown date and used electric heating pad on (b)(6) 2016 for a couple of days, for an hour at a time.There were no concomitant medications.The patient previously took thermacare heatwraps menstrual products on for 8 hours, never had a burn and never had a problem.The patient had the product on for 4 hours on (b)(6) 2016, and afterwards, about an hour and a half later, she felt like a sting and could not rub across it.If clothing touched it, she could feel the pain, and that is what made her go look.She saw little pink spots on her lower back, in the area of her tattoo and around it.It looked like her skin had been taken off, it had little pink spots on her back.She has been rubbing vaseline on the burn.The burn was trying to heal up.The action taken of the product was permanent withdrawn on (b)(6) 2016.The outcome of the event was recovering.The patient classified skin tone is medium/dark, no sensitive skin, no abnormal skin conditions, she did not sleep while wearing the product, not wearing several layers of clothing over the thermacare product, no wearing a snug waistband/belt or similar or otherwise applied pressure over the area, attached the adhesive to body, not engage in exercise while using the product, checked skin under the product while wearing thermacare, she took it off for a few minutes to check and readjusted it and put it back and she did this about 3 times over 4 hours.Additional information has been requested and will be provided as it becomes available.Follow-up (13jun2016): this contactable consumer reported in consumer's claim by way of medical records and consumer questionnaire.This female patient applied thermacare heatwrap (thermacare lower back & hip) large to extra large (l-xl) for lower back pain.It was reported that, the lot number was l-70230, expiration date was feb2018 and ndc code was 0573301001.Her social history included alcohol use (wine and liquor) 2-4 per week on an unknown date.Her family history included diabetes (father) and hypertension (father and mother) on an unknown date.Her past drug history included thermacare menstrual heating pad several times and never had an issue and it was placed directly on her skin.On the day after application of product, she had discomfort pain in her lower back and the skin was burnt in different spots and was diagnosed with first degree burn.It was reported that, her skin was little pinkish and no skin on those spots.She had rash and it was described as blistering, itching, tender but not red, scaling, spreading, warm to touch, weeping and ulcerated.It was reported that, she was still experiencing burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off.She was hospitalized on an unknown date for looked like her skin had been taken off.On an unknown date, she was treated with unknown over the counter (otc) creams to apply on her skin and pain has getting better.She was received an unknown treatment for burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off.As of 13jun2016, the clinical outcome of the events burnt her back it had little pink spots on her back/feel the pain and looked like her skin had been taken off was not recovered.Follow-up (28jun2016): this contactable consumer reported in consumer's claim by way of consumer questionnaire.This female patient purchased thermacare heatwrap (thermacare lower back & hip) from wal-mart in mar2016 and applied only for one day in mar2016 on her lower back.She left the product 1-2 hours on at one time during the course of 24 hours.It was stated that the skin was damaged or broken prior to usage, but did not experienced bruised or swelled 48 hours prior to usage of product.She placed the product over her clothing and did not detect irritation, redness or burning during usage.In mar2016, she experienced uncomfortable feeling on the back and burning sensation in different area.On the same day, she was diagnosed with second degree burn.She was prescribed with a topical cream and referred to a dermatologist.The dermatologist provided a higher grade topical cream and she applied daily.As of 28jun2016, the clinical outcome of the event second degree burn was unknown.Follow-up (14oct2019): this is a follow-up report from product quality complaint group included: this record was identified during the thermacare remediation review as not being a duplicate record and therefore requires reopening and forwarding to the site for investigation.The reporter's occupation was corrected from attorney to consumer.
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Search Alerts/Recalls
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