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| Lot Number M59540 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Scratched Material (3020); Noise, Audible (3273)
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| Patient Problems
Pain (1994); Burn, Thermal (2530)
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Event Type
Injury
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Event Description
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Burnt at the back area and she got scab/may be about 4th of an inch or half inch long in her lower back, it's on the right side [thermal burn] burnt at the back area and she got scab [scab] when she grabbed her hands across, there was something on her hand and she realized that it was a piece of skin [skin exfoliation] used the wrap directly against the skin/had to put another bandage over it to put another thermacare wrap on it [intentional device misuse] little pins down there that are really exposed and they feel like they are rough or something/at the last minute, it's like those things heated up [product quality issue].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) years-old caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number m59540, expiration date sep2018, from an unspecified date to an unspecified date at an unknown frequency for back pain.Medical history included three back surgeries the first was in 2003, burn that got majorly infected, she was physically disabled.During those surgeries, they did permanent muscle and nerve damage and now she could not do hardly anything like she could not sit and stand for long time, "nothing hurts, she can't hardly breathe".The patient's concomitant medications were not reported.The patient reported she wore thermacare wraps all the time, she had three major back surgeries, she had really severe back pain and she had thermacare on two days ago.She came downstairs to get ready for bed and all of sudden she thought that someone was biting her, so she reached back there and she did not feel anything, but when she grabbed her hands across, there was something on her hand and she realized that it was a piece of skin.She asked her boyfriend and he (her boyfriend) said that it was burnt.She mentioned there are little pins down there that are really exposed and they feel like they are rough or something, but she had used it all the day and it did not do that, just at the last minute, it's like those things heated up or something and it burnt her on an unspecified date with outcome of unknown.She did not know the size of the burn and further added that the size was maybe about 4th of an inch or half inch long in her lower back, it's on the right side.She mentioned that there was no drainage of pus from the burn and further added that she just put a bandage on it.She was just burnt at the back area and she got scab on it and she had to put another bandage over it to put another thermacare wrap on it as she said she wears thermacare all the time and never had this happened.She did not see any doctor for this burn and further added that in the past when she gotten burnt before she had lot of health problems, she had a burn before that gotten majorly infected and that's why she was really trying to keep eye on it or else she had to go to burn unit.She mentioned that there was no defect on the wrap and further added that, that was the first time she looked for and realized that it burnt her and just only thing there was one that "sounds like pieces" like popped out or something and was kind of sharp and she was not sure what happened, she really did not know what happened and she never had this happen, she had been using this product for years.She did not change or modify the wrap in any way.She did not feel that the wrap was getting too hot and further added that when it burnt her it was just like a sudden, just like she got electrocuted and this happened like bam, when she took her hand back to feel that she couldn't touch it as it was so painful.She had light skin tone.She did not use any creams, rubs or gels under the wrap.She had been using the product from years and further added that ever since she had her first surgery back in 2003 she had been using them.She used the wrap directly against the skin.She did not overlap the wrap in anyway.The action taken with thermacare heatwrap was unknown.Company clinical evaluation comment based on the information provided, the events thermal burn, scab, skin exfoliation, intentional device misuse, and product quality issue as described in this case represent serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well -being of the user, considered associated with device use.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn, scab, skin exfoliation, intentional device misuse, and product quality issue as described in this case represent serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well -being of the user, considered associated with device use.This case meets initial 10-day eu and 30-day fda reportability.
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Event Description
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Burnt at the back area, blistered up and she got scab, about 4th of an inch or half inch long on the right side of her lower back [burns second degree].Burnt at the back area and she got scab [scab].When she grabbed her hands across, there was something on her hand and she realized that it was a piece of skin [skin exfoliation].Used wrap directly against skin/put another bandage over it to put another wrap on it, used wrap 8-9 hours per day [intentional device misuse].Little pins down there that are really exposed and they feel like they are rough or something/at the last minute, it's like those things heated up [product quality issue].Case description: this is a spontaneous report from a contactable consumer.A (b)(6)-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: m59540, expiration date: sep2018) from an unspecified date for back pain.Medical history included rheumatoid arthritis from an unspecified date and unknown if ongoing, three back surgeries the first was in 2003, burn that got majorly infected and she was physically disabled.During those surgeries they did permanent muscle and nerve damage and now she could not do hardly anything like she could not sit and stand for long time, "nothing hurts, she can't hardly breathe".The patient's concomitant medications included norco at 10/325 mg, 4-6 times daily for back pain, oxycodone at 30 mg, 4-6 times daily for back pain and remeron at 1 dose form daily for appetite to gain weight.The patient reported she wore thermacare wraps all the time, she had three major back surgeries, she had really severe back pain and she had thermacare on two days ago.The patient had applied the heatwrap at approximately 11:00 am until approximately 7:00 pm.She came downstairs to get ready for bed and all of a sudden it felt like something had bit her.She reached back there and she did not feel anything, but when she grabbed her hands across, there was something on her hand and she realized that it was a piece of skin.She asked her boyfriend and he (her boyfriend) said that it was burnt.She mentioned there are little pins down there that are really exposed and they feel like they are rough or something, but she had used it all day and it did not do that, just at the last minute.It was like those things heated up or something and it burnt her on an unspecified date.She did not know the size of the burn and further added that the size was maybe about 4th of an inch or half inch long on the right side of her lower back.She mentioned there was no drainage of pus from the burn and further added she just put a bandage on it.She was just burnt at the back area which blistered up and she got a scab on it and she had to put another bandage over it to put another thermacare wrap on it.She did not see a doctor for this burn and further added that in the past when she had gotten burnt before she had a lot of health problems.She had a burn before that had gotten majorly infected and that's why she was really trying to keep eye on it or else she had to go to burn unit.The patient stated there were no defects in the wrap and further added that was the first time she looked for and realized that it burnt her and just only thing there was one that "sounds like pieces" like popped out or something and was kind of sharp and she was not sure what happened.The patient did not know what happened and she never had this happen, she had been using this product for years.The patient assessed her skin tone as medium.She did not change or modify the wrap in any way.The patient did not feel that the wrap was getting too hot and further added that when it burnt her it was just like a sudden, just like she got electrocuted and this happened like bam, when she took her hand back to feel that she couldn't touch it as it was so painful.She denied having sensitive skin or any abnormal skin conditions.The patient did not use any creams, rubs or gels under the wrap.She had been using the product for years and further added that ever since she had her first surgery back in 2003 she had been using them.She used the wrap directly against the skin.The patient did not overlap the wrap in anyway.She had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) without any adverse effects.The patient did not exercise while using the wrap.She did not check the skin under the wrap during use.The patient had read the usage instructions prior to using the product.Action taken with thermacare heatwrap was continued.Therapeutic measures taken included an unspecified cream.No hospitalization was required as a result of the events.Clinical outcome of the event scab was not resolved.Clinical outcome of the remaining events was resolved on an unspecified date.Follow-up ((b)(6) 2016): new information received from a contactable consumer includes: additional medical history, concomitant medications, action taken with suspect product, therapeutic measures taken, no hospitalization required, reaction data (updated event burn to burn blister) and events outcome.Company clinical evaluation comment based on the information provided, the events burn second degree, scab, skin exfoliation, intentional device misuse, and product quality issue as described in this case represent serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well -being of the user, considered associated with device use.This case meets follow up 10-day (b)(4) and 30-day fda reportability.Case comment: based on the information provided, the events burn second degree, scab, skin exfoliation, intentional device misuse, and product quality issue as described in this case represent serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well -being of the user, considered associated with device use.This case meets follow up 10-day (b)(4) and 30-day fda reportability.
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Manufacturer Narrative
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New information received from product quality complaint (pqc) group on 15apr2016 includes investigation results.This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trend has been identified with this batch as it relates to cell damage.No additional action will be taken at this time.The consumer returned wraps did not have damaged or leaking heat cell packs.The root cause of the alleged heat cell pack damage/leak is inconclusive.Additional information received from pqc group on 03may2016 includes investigation results specific to the alleged burn from thermacare heatwraps.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 cause of the alleged burn from a wrap 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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Burnt at the back area, blistered up and she got scab, about 4th of an inch or half inch long on the right side of her lower back [burns second degree].Burnt at the back area and she got scab [scab].When she grabbed her hands across, there was something on her hand and she realized that it was a piece of skin [skin exfoliation].Used wrap directly against skin, put another bandage over it to put another wrap on it, used wrap 8-9 hours per day/she wears therma wraps all the times [intentional device misuse].Little pins down there that are really exposed and they feel like they are rough or something/at the last minute, it's like those things heated up [product quality issue].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: m59540, expiration date: sep2018) from an unspecified date for back pain.Medical history included rheumatoid arthritis from an unspecified date and unknown if ongoing, three back surgeries the first was in 2003, burn that got majorly infected and she was physically disabled.During those surgeries they did permanent muscle and nerve damage and now she could not do hardly anything like she could not sit and stand for long time, "nothing hurts, she can't hardly breathe".The patient's concomitant medications included norco at 10/325 mg, 4-6 times daily for back pain, oxycodone at 30 mg, 4-6 times daily for back pain and remeron at 1 dose form daily for appetite to gain weight.The patient reported she wore thermacare wraps all the time, she had three major back surgeries, she had really severe back pain and she had thermacare on two days ago.The patient had applied the heatwrap at approximately 11:00 am until approximately 7:00 pm.She came downstairs to get ready for bed and all of a sudden it felt like something had bit her.She reached back there and she did not feel anything, but when she grabbed her hands across, there was something on her hand and she realized that it was a piece of skin.She asked her boyfriend and he (her boyfriend) said that it was burnt.She mentioned there are little pins down there that are really exposed and they feel like they are rough or something, but she had used it all day and it did not do that, just at the last minute.It was like those things heated up or something and it burnt her on an unspecified date.She did not know the size of the burn and further added that the size was maybe about 4th of an inch or half inch long on the right side of her lower back.She mentioned there was no drainage of pus from the burn and further added she just put a bandage on it.She was just burnt at the back area which blistered up and she got a scab on it and she had to put another bandage over it to put another thermacare wrap on it.She did not see a doctor for this burn and further added that in the past when she had gotten burnt before she had a lot of health problems.She had a burn before that had gotten majorly infected and that's why she was really trying to keep eye on it or else she had to go to burn unit.The patient stated there were no defects in the wrap and further added that was the first time she looked for and realized that it burnt her and just only thing there was one that "sounds like pieces" like popped out or something and was kind of sharp and she was not sure what happened.The patient did not know what happened and she never had this happen, she had been using this product for years.The patient assessed her skin tone as medium.She did not change or modify the wrap in any way.The patient did not feel that the wrap was getting too hot and further added that when it burnt her it was just like a sudden, just like she got electrocuted and this happened like bam, when she took her hand back to feel that she couldn't touch it as it was so painful.She denied having sensitive skin or any abnormal skin conditions.The patient did not use any creams, rubs or gels under the wrap.She had been using the product for years and further added that ever since she had her first surgery back in 2003 she had been using them.She used the wrap directly against the skin.The patient did not overlap the wrap in anyway.She had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) without any adverse effects.The patient did not exercise while using the wrap.She did not check the skin under the wrap during use.The patient had read the usage instructions prior to using the product.Action taken with thermacare heatwrap was continued.Therapeutic measures taken included an unspecified cream.No hospitalization was required as a result of the events.Clinical outcome of the event scab was not resolved.Clinical outcome of the remaining events was resolved on an unspecified date.New information received from product quality complaint (pqc) group on 15apr2016 includes investigation results.This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trend has been identified with this batch as it relates to cell damage.No additional action will be taken at this time.The consumer returned wraps did not have damaged or leaking heat cell packs.The root cause of the alleged heat cell pack damage/leak is inconclusive.Additional information received from pqc group on 03may2016 includes investigation results specific to the alleged burn from thermacare heatwraps.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 cause of the alleged burn from a wrap is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Follow-up (29mar2016): new information received from a contactable consumer includes: additional medical history, concomitant medications, action taken with suspect product, therapeutic measures taken, no hospitalization required, reaction data (updated event burn to burn blister) and events outcome.Follow-up (15apr2016): new information received from product quality complaints (pqc) group included: updated suspect product and provided product quality investigation results.Follow-up (03may2016): new information received from product quality complaints (pqc) group included: additional product quality investigation results specific to the alleged burn from thermacare heatwraps.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events burn second degree, scab, skin exfoliation, intentional device misuse, and product quality issue as described in this case represent serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well -being of the user, considered associated with device use.No device malfunction has been identified.This case meets final 10-day eu and 30-day fda reportability.Evaluation summary new information received from product quality complaint (pqc) group on 15apr2016 includes investigation results.This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trend has been identified with this batch as it relates to cell damage.No additional action will be taken at this time.The consumer returned wraps did not have damaged or leaking heat cell packs.The root cause of the alleged heat cell pack damage/leak is inconclusive.Additional information received from pqc group on 03may2016 includes investigation results specific to the alleged burn from thermacare heatwraps.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 cause of the alleged burn from a wrap 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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Manufacturer Narrative
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This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trend has been identified with this batch as it relates to cell damage.No additional action will be taken at this time.The consumer returned wraps did not have damaged or leaking heat cell packs.The root cause of the alleged heat cell pack damage/leak is inconclusive.
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Event Description
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Burnt at the back area, blistered up and she got scab, about 4th of an inch or half inch long on the right side of her lower back [burns second degree].Burnt at the back area and she got scab [scab].When she grabbed her hands across, there was something on her hand and she realized that it was a piece of skin [skin exfoliation].Used wrap directly against skin, put another bandage over it to put another wrap on it, used wrap 8-9 hours per day [intentional device misuse].Little pins down there that are really exposed and they feel like they are rough or something/at the last minute, it's like those things heated up [product quality issue].Case description: this is a spontaneous report from a contactable consumer.A (b)(6)-year-old caucasian female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: m59540, expiration date: sep2018) from an unspecified date for back pain.Medical history included rheumatoid arthritis from an unspecified date and unknown if ongoing, three back surgeries the first was in 2003, burn that got majorly infected and she was physically disabled.During those surgeries they did permanent muscle and nerve damage and now she could not do hardly anything like she could not sit and stand for long time, "nothing hurts, she can't hardly breathe".The patient's concomitant medications included norco at 10/325 mg, 4-6 times daily for back pain, oxycodone at 30 mg, 4-6 times daily for back pain and remeron at 1 dose form daily for appetite to gain weight.The patient reported she wore thermacare wraps all the time, she had three major back surgeries, she had really severe back pain and she had thermacare on two days ago.The patient had applied the heatwrap at approximately 11:00 am until approximately 7:00 pm.She came downstairs to get ready for bed and all of a sudden it felt like something had bit her.She reached back there and she did not feel anything, but when she grabbed her hands across, there was something on her hand and she realized that it was a piece of skin.She asked her boyfriend and he (her boyfriend) said that it was burnt.She mentioned there are little pins down there that are really exposed and they feel like they are rough or something, but she had used it all day and it did not do that, just at the last minute.It was like those things heated up or something and it burnt her on an unspecified date.She did not know the size of the burn and further added that the size was maybe about 4th of an inch or half inch long on the right side of her lower back.She mentioned there was no drainage of pus from the burn and further added she just put a bandage on it.She was just burnt at the back area which blistered up and she got a scab on it and she had to put another bandage over it to put another thermacare wrap on it.She did not see a doctor for this burn and further added that in the past when she had gotten burnt before she had a lot of health problems.She had a burn before that had gotten majorly infected and that's why she was really trying to keep eye on it or else she had to go to burn unit.The patient stated there were no defects in the wrap and further added that was the first time she looked for and realized that it burnt her and just only thing there was one that "sounds like pieces" like popped out or something and was kind of sharp and she was not sure what happened.The patient did not know what happened and she never had this happen, she had been using this product for years.The patient assessed her skin tone as medium.She did not change or modify the wrap in any way.The patient did not feel that the wrap was getting too hot and further added that when it burnt her it was just like a sudden, just like she got electrocuted and this happened like bam, when she took her hand back to feel that she couldn't touch it as it was so painful.She denied having sensitive skin or any abnormal skin conditions.The patient did not use any creams, rubs or gels under the wrap.She had been using the product for years and further added that ever since she had her first surgery back in 2003 she had been using them.She used the wrap directly against the skin.The patient did not overlap the wrap in anyway.She had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) without any adverse effects.The patient did not exercise while using the wrap.She did not check the skin under the wrap during use.The patient had read the usage instructions prior to using the product.Action taken with thermacare heatwrap was continued.Therapeutic measures taken included an unspecified cream.No hospitalization was required as a result of the events.Clinical outcome of the event scab was not resolved.Clinical outcome of the remaining events was resolved on an unspecified date.New information received from product quality complaint (pqc) group includes investigation results.This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trend has been identified with this batch as it relates to cell damage.No additional action will be taken at this time.The consumer returned wraps did not have damaged or leaking heat cell packs.The root cause of the alleged heat cell pack damage/leak is inconclusive.Follow-up (29mar2016): new information received from a contactable consumer includes: additional medical history, concomitant medications, action taken with suspect product, therapeutic measures taken, no hospitalization required, reaction data (updated event burn to burn blister) and events outcome.Follow-up (15apr2016): new information received from product quality complaints (pqc) group included: updated suspect product and provided product quality investigation results.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the events burn second degree, scab, skin exfoliation, intentional device misuse, and product quality issue as described in this case represent serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well -being of the user, considered associated with device use.No device malfunction has been identified.This case meets final (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events burn second degree, scab, skin exfoliation, intentional device misuse, and product quality issue as described in this case represent serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well -being of the user, considered associated with device use.No device malfunction has been identified.This case meets final (b)(6) and 30-day fda reportability.Continued: evaluation summary: this batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trend has been identified with this batch as it relates to cell damage.No additional action will be taken at this time.The consumer returned wraps did not have damaged or leaking heat cell packs.The root cause of the alleged heat cell pack damage/leak is inconclusive.
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Search Alerts/Recalls
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