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| Device Problems
Use of Device Problem (1670); Material Protrusion/Extrusion (2979); Insufficient Information (3190)
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| Patient Problems
Emotional Changes (1831); Irritation (1941); Pain (1994); Ulcer (2274); Sleep Dysfunction (2517); Burn, Thermal (2530)
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| Event Date 08/28/2017 |
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Event Type
Injury
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Event Description
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Two (2) open sores on lower back the size of the ovals on heat wrap [ulcer] , she is really upset about it because her skin is burnt [thermal burn] , couldn't sleep last night [insomnia] ,.Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6) female consumer started to receive thermacare heatwrap (thermacare heatwrap) at unknown frequency on (b)(6) 2017 for very bad arthritis in lower back and chronic pain all the time.Medical history included chronic back pain for 10 years and had bursitis in her left hip and was just hoping for some pain relief, stated she stopped going to the orthopedic because all they want to do was give her cortisone.Concomitant medications were not reported.Consumer purchased a two-pack box of thermacare heatwraps from her local pharmacy.She did not know the exact name/type of wrap as she did not have the box, knows it came in a red box.She thought it said to wrap it around your back where your pain was.The box had 2 wraps that were not individually wrapped, there was no plastic or anything to open them up or anything, and they had 16 oval heat things inside.She used it yesterday and put it around her lower back, she didn't even leave it on 16 hours, thinks she left it on maybe 8.She went to take it off to maybe rewrap it and she touched her backside and it had made sores that were so bad that her skin was open and now there is 2 sores the size of the little ovals, one is worse than the other.She had to wash her body, put neosporin on there, and then a great big bandage to cover it.She was really upset about it because her skin was burnt.She had red marks all over her back.Added that if she would have left the wrap on for 16 hours, it might have made more sores.She had to keep readjusting it because it kept sliding, the one on her hip did not work because it kept sliding because you can't wrap it around your hip like that.So she put the second one higher up on her back, above the one on her lower back.The one on the lower back was the one that really screwed things up and she was really pissed off.She spoke to a nurse that is part of the company that helped provide help at her some and was advised to take a shower, put neosporin on it, and keep it dry.She wanted some compensation because it really hurt, that was not the way it is supposed to work.Added she was in a lot of pain and couldn't sleep last night.Consumer stated this was a permanent stop of the product and that she won't buy anymore thermacare and maybe even pfizer products because it burnt the crap out of her back.A sample of the product was available to be returned.Consumer stated that she had pictures that she could send if needed.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2017.The outcome of 2 open sores on lower back the size of the ovals on heat wrap was not resolved.The outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "2 sores the size of the little ovals""skin was burnt" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "couldn't sleep" is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "2 sores the size of the little ovals""skin was burnt" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "couldn't sleep" is non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term].She is really upset about it because her skin is burnt/instead of relief i got burned [thermal burn], 2 open sores on lower back the size of the ovals on heat wrap [ulcer], couldn't sleep last night [insomnia].Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6) -year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) at unknown frequency on (b)(6) 2017 for very bad arthritis in lower back and chronic pain all the time.Medical history included chronic back pain for 10 years and had bursitis in her left hip and was just hoping for some pain relief, stated she stopped going to the orthopedic because all they want to do was give her cortisone.Concomitant medications were not reported.Consumer purchased a two-pack box of thermacare heatwraps from her local pharmacy.The wrap came in a red box.She thought it said to wrap it around your back where your pain was.The box had 2 wraps that were not individually wrapped, there was no plastic or anything to open them up or anything, and they had 16 oval heat things inside.She used it yesterday and put it around her lower back, she didn't even leave it on 16 hours, thinks she left it on maybe 8.She went to take it off to maybe rewrap it and she touched her backside and it had made sores that were so bad that her skin was open and now there is 2 sores the size of the little ovals, one is worse than the other.She had to wash her body, put neosporin on there, and then a great big bandage to cover it.She was really upset about it because her skin was burnt.She had red marks all over her back.Added that if she would have left the wrap on for 16 hours, it might have made more sores.She had to keep readjusting it because it kept sliding, the one on her hip did not work because it kept sliding because you can't wrap it around your hip like that.So she put the second one higher up on her back, above the one on her lower back.The one on the lower back was the one that really screwed things up and she was really pissed off.She spoke to a nurse that is part of the company that helped provide help at her some and was advised to take a shower, put neosporin on it, and keep it dry.She wanted some compensation because it really hurt, that was not the way it is supposed to work.Added she was in a lot of pain and couldn't sleep last night.Consumer stated this was a permanent stop of the product and that she won't buy anymore thermacare and maybe even pfizer products because it burnt the crap out of her back.A sample of the product was available to be returned.Consumer stated that she had pictures that she could send if needed.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2017.The outcome of 2 open sores on lower back the size of the ovals on heat wrap was not resolved.The outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2017): new information from a contactable consumer includes: suspect product trade name.Company clinical evaluation comment based on the information provided, the events of "2 sores the size of the little ovals""skin was burnt" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "couldn't sleep" is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "2 sores the size of the little ovals""skin was burnt" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "couldn't sleep" is non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] she is really upset about it because her skin is burnt/instead of relief i got burned/was burned on 2 places on lower back.Skin came off on her fingers/ my main complaint was the burning [thermal burn] , 2 open sores on lower back the size of the ovals on heat wrap [ulcer] , couldn't sleep last night [insomnia] ,.Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6) -year-old (b)(6) female consumer started to receive thermacare heatwrap (thermacare lower back & hip) at unknown frequency on (b)(6) 2017 for very bad arthritis in lower back and chronic pain all the time.Medical history included chronic back pain for 10 years and had bursitis in her left hip and was just hoping for some pain relief, stated she stopped going to the orthopedic because all they want to do was give her cortisone, patient also had mastectomy.Concomitant medications were none.Consumer purchased a two-pack box of thermacare heatwraps from her local pharmacy.The wrap came in a red box.She thought it said to wrap it around your back where your pain was.The box had 2 wraps that were not individually wrapped, there was no plastic or anything to open them up or anything, and they had 16 oval heat things inside.She used it yesterday and put it around her lower back, she didn't even leave it on 16 hours, thinks she left it on maybe 8.She went to take it off to maybe rewrap it and she touched her backside and it had made sores that were so bad that her skin was open and now there was 2 sores the size of the little ovals, one was worse than the other ((b)(6) 2017).She had to wash her body, put neosporin on there, and then a great big bandage to cover it.She was really upset about it because her skin was burnt.She had red marks all over her back.Added that if she would have left the wrap on for 16 hours, it might have made more sores.She had to keep readjusting it because it kept sliding, the one on her hip did not work because it kept sliding because you can't wrap it around your hip like that.So she put the second one higher up on her back, above the one on her lower back.The one on the lower back was the one that really screwed things up and she was really pissed off.She spoke to a nurse that was part of the company that helped provide help at her some and was advised to take a shower, put neosporin on it, and keep it dry.She wanted some compensation because it really hurt, that was not the way it was supposed to work.Added she was in a lot of pain and couldn't sleep last night on (b)(6) 2017, no treatment for couldn't sleep.Consumer stated this was a permanent stop of the product and that she won't buy anymore thermacare and maybe even pfizer products because it burnt the crap out of her back.A sample of the product was available to be returned.Consumer stated that she had pictures that she could send if needed.Consumer stated this happened on (b)(6) 2017.She called on (b)(6) 2017.She went to the doctor twice and he ordered silvadene cream and a tetanus shot.She added that she was sent paperwork asking her to fill out.She did not have the box to provide ncd, lot or expiry.She went to pharmacy where she purchased it to try to get information.The product was in a (mailer service).She was planning on sending it back but had not yet.She could not find ncd, lot or expiry.She added they were 2 wraps in a red box.She asked the lady to clean her house to help her get it on.She tried to put around hips and legs.8 hours later she took it off and skin came off on her finger.She had already reported the burn.Adds that there were 16 ovals on the pack and you could see the ovals on her back.She emailed pictures of lower back side.It showed the 2 places where she was burned.She had the product on only for 8 hours.She was burned severely.It had cleared up since them.The patient was not hospitalized due to the events.The patient reported "i did not keep box once i put wrap on was in trash." the patient was not pregnant or post-menopausal.Skin tone was medium.The patient not have sensitive skin or abnormal skin conditions.The patient did not previously use other heat products for pain.The patient did not engage in exercise while using the product.The patient checked skin every 2 hrs under the product while wearing thermacare.The patient read the usage instructions on thermacare before used the product.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2017.The outcome of 2 open sores on lower back the size of the ovals on heat wrap and burn was not resolved.The outcome of couldn't sleep last night was recovered on unknown date in 2017.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2017): new information from a contactable consumer includes: suspect product trade name.Follow-up ((b)(6) 2017): new information received from the same contactable consumer included: events details.Follow-up ((b)(6) 2017): new information received from a contactable consumer reported in response to non hcp letter included that: medical history, concomitant drug information, patient's information, event couldn't sleep last night onset date, patient hospitalization information, event treatment information and outcome.Company clinical evaluation comment based on the information provided, the events of "2 sores the size of the little ovals""skin was burnt" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "couldn't sleep" is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "2 sores the size of the little ovals""skin was burnt" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "couldn't sleep" is non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] she is really upset about it because her skin is burnt/instead of relief i got burned/was burned on 2 places on lower back.Skin came off on her fingers/ my main complaint was the burning [thermal burn] , 2 open sores on lower back the size of the ovals on heat wrap [ulcer] , couldn't sleep last night [insomnia] ,.Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6)-year-old caucasian female consumer started to receive thermacare heatwrap (thermacare lower back & hip) at unknown frequency on (b)(6) 2017 for very bad arthritis in lower back and chronic pain all the time.Medical history included chronic back pain for 10 years and had bursitis in her left hip and was just hoping for some pain relief, stated she stopped going to the orthopedic because all they want to do was give her cortisone, patient also had mastectomy.Concomitant medications were none.Consumer purchased a two-pack box of thermacare heatwraps from her local pharmacy.The wrap came in a red box.She thought it said to wrap it around your back where your pain was.The box had 2 wraps that were not individually wrapped, there was no plastic or anything to open them up or anything, and they had 16 oval heat things inside.She used it yesterday and put it around her lower back, she didn't even leave it on 16 hours, thinks she left it on maybe 8.She went to take it off to maybe rewrap it and she touched her backside and it had made sores that were so bad that her skin was open and now there was 2 sores the size of the little ovals, one was worse than the other (28aug2017).She had to wash her body, put neosporin on there, and then a great big bandage to cover it.She was really upset about it because her skin was burnt.She had red marks all over her back.Added that if she would have left the wrap on for 16 hours, it might have made more sores.She had to keep readjusting it because it kept sliding, the one on her hip did not work because it kept sliding because you can't wrap it around your hip like that.So she put the second one higher up on her back, above the one on her lower back.The one on the lower back was the one that really screwed things up and she was really pissed off.She spoke to a nurse that was part of the company that helped provide help at her some and was advised to take a shower, put neosporin on it, and keep it dry.She wanted some compensation because it really hurt, that was not the way it was supposed to work.Added she was in a lot of pain and couldn't sleep last night on (b)(6) 2017, no treatment for couldn't sleep.Consumer stated this was a permanent stop of the product and that she won't buy anymore thermacare and maybe even pfizer products because it burnt the crap out of her back.A sample of the product was available to be returned.Consumer stated that she had pictures that she could send if needed.Consumer stated this happened on (b)(6) 2017.She called on (b)(6) 2017.She went to the doctor twice and he ordered silvadene cream and a tetanus shot.She added that she was sent paperwork asking her to fill out.She did not have the box to provide ncd, lot or expiry.She went to pharmacy where she purchased it to try to get information.The product was in a (mailer service).She was planning on sending it back but had not yet.She could not find ncd, lot or expiry.She added they were 2 wraps in a red box.She asked the lady to clean her house to help her get it on.She tried to put around hips and legs.Eight hours later she took it off and skin came off on her finger.She had already reported the burn.Adds that there were 16 ovals on the pack and you could see the ovals on her back.She emailed pictures of lower back side.It showed the 2 places where she was burned.She had the product on only for 8 hours.She was burned severely.It had cleared up since them.The patient was not hospitalized due to the events.The patient reported "i did not keep box once i put wrap on was in trash." the patient was not pregnant or post-menopausal.Skin tone was medium.The patient not have sensitive skin or abnormal skin conditions.The patient did not previously use other heat products for pain.The patient did not engage in exercise while using the product.The patient checked skin every 2 hrs under the product while wearing thermacare.The patient read the usage instructions on thermacare before used the product.The action taken in response to the events of the product was permanently discontinued on (b)(6)2017.The outcome of 2 open sores on lower back the size of the ovals on heat wrap and burn was not resolved.The outcome of couldn't sleep last night was recovered on unknown date in 2017.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2017): new information from a contactable consumer includes: suspect product trade name.Follow-up ((b)(6) 2017): new information received from the same contactable consumer included: events details.Follow-up ((b)(6) 2017): new information received from a contactable consumer reported in response to non hcp letter included that: medical history, concomitant drug information, patient's information, event couldn't sleep last night onset date, patient hospitalization information, event treatment information and outcome.Company clinical evaluation comment based on the information provided, the events of "2 sores the size of the little ovals""skin was burnt" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "couldn't sleep" is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "2 sores the size of the little ovals""skin was burnt" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "couldn't sleep" is non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] she is really upset about it because her skin is burnt/instead of relief i got burned/was burned on 2 places on lower back.Skin came off on her fingers/ my main complaint was the burning [thermal burn] , 2 open sores on lower back the size of the ovals on heat wrap [ulcer] , directly applied the heat wrap to the skin around her base lower back [device use error] , couldn't sleep last night [insomnia] ,.Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6)-year-old caucasian female consumer started to receive thermacare heatwrap (thermacare lower back & hip) at unknown frequency on (b)(6) 2017 for very bad arthritis in lower back and chronic pain all the time.Medical history included chronic back pain for 10 years and had bursitis in her left hip and was just hoping for some pain relief, stated she stopped going to the orthopedic because all they want to do was give her cortisone, patient also had mastectomy.Concomitant medications were none.Consumer purchased a two-pack box of thermacare heatwraps from her local pharmacy.The wrap came in a red box.She thought it said to wrap it around your back where your pain was.The box had 2 wraps that were not individually wrapped, there was no plastic or anything to open them up or anything, and they had 16 oval heat things inside.She used it yesterday and put it around her lower back, she didn't even leave it on 16 hours, thinks she left it on maybe 8.She went to take it off to maybe rewrap it and she touched her backside and it had made sores that were so bad that her skin was open and now there was 2 sores the size of the little ovals, one was worse than the other (28aug2017).She had to wash her body, put neosporin on there, and then a great big bandage to cover it.She was really upset about it because her skin was burnt.She had red marks all over her back.Added that if she would have left the wrap on for 16 hours, it might have made more sores.She had to keep readjusting it because it kept sliding, the one on her hip did not work because it kept sliding because you can't wrap it around your hip like that.So she put the second one higher up on her back, above the one on her lower back.The one on the lower back was the one that really screwed things up and she was really pissed off.She spoke to a nurse that was part of the company that helped provide help at her some and was advised to take a shower, put neosporin on it, and keep it dry.She wanted some compensation because it really hurt, that was not the way it was supposed to work.Added she was in a lot of pain and couldn't sleep last night on (b)(6) 2017, no treatment for couldn't sleep.Consumer stated this was a permanent stop of the product and that she won't buy anymore thermacare and maybe even pfizer products because it burnt the crap out of her back.A sample of the product was available to be returned.Consumer stated that she had pictures that she could send if needed.Consumer stated this happened on (b)(6) 2017.She called on (b)(6) 2017.She went to the doctor twice and he ordered silvadene cream and a tetanus shot.She added that she was sent paperwork asking her to fill out.She did not have the box to provide ncd, lot or expiry.She went to pharmacy where she purchased it to try to get information.The product was in a (mailer service).She was planning on sending it back but had not yet.She could not find ncd, lot or expiry.She added they were 2 wraps in a red box.She asked the lady to clean her house to help her get it on.She tried to put around hips and legs.Eight hours later she took it off and skin came off on her finger.She had already reported the burn.Adds that there were 16 ovals on the pack and you could see the ovals on her back.She emailed pictures of lower back side.It showed the 2 places where she was burned.She had the product on only for 8 hours.She was burned severely.It had cleared up since them.The patient was not hospitalized due to the events.The patient reported "i did not keep box once i put wrap on was in trash." the patient was not pregnant or post-menopausal.Skin tone was medium.The patient not have sensitive skin or abnormal skin conditions.The patient did not previously use other heat products for pain.The patient did not engage in exercise while using the product.The patient checked skin every 2 hrs under the product while wearing thermacare.The patient read the usage instructions on thermacare before used the product.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2017.The outcome of 2 open sores on lower back the size of the ovals on heat wrap and burn was not resolved.The outcome of couldn't sleep last night was recovered on unknown date in 2017.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2017): new information from a contactable consumer includes: suspect product trade name.Follow-up ((b)(6) 2017): new information received from the same contactable consumer included: events details.Follow-up ((b)(6) 2017): new information received from a contactable consumer reported in response to non hcp letter included that: medical history, concomitant drug information, patient's information, event couldn't sleep last night onset date, patient hospitalization information, event treatment information and outcome.Company clinical evaluation comment based on the information provided, the events of "2 sores the size of the little ovals""skin was burnt" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "couldn't sleep" is non-serious.The events are medically assessed as associated with the use of the device.Follow-up ((b)(6) 2017): this contactable consumer reported by way of consumer questionnaire.This female patient used thermacare heatwrap (thermacare lower back and hip) on (b)(6) 2017 and she discontinued to use thermacare heatwrap after using it for approximately 8 hours on (b)(6) 2017.Alternatively it was reported that the patient used thermacare heat wrap for less than one day.On (b)(6) 2017, she directly applied the heat wrap to the skin around her base lower back and checked the skin frequently.On an unknown date, after using thermacare she developed 16 red marks and 2 severe burns open sores.The wrap was not heated in microwave and neither re heated at all during usage.It was reported that she was under the medical care of a physician for burns.As of (b)(6) 2017, the clinical outcome of the event directly applied the heat wrap to the skin around her base lower back was unknown.
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Event Description
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Event verbatim [preferred term].Directly applied the heat wrap to the skin/put the second one higher up on her back, above the one on her lower back/put around hips and legs/read the usage instructions [intentional device misuse].She is really upset about it because her skin is burnt/instead of relief i got burned/was burned on 2 places on lower back.Skin came off on her fingers/ my main complaint was the burning [thermal burn].2 open sores on lower back the size of the ovals on heat wrap [ulcer], couldn't sleep last night [insomnia], did not work [device ineffective], kept sliding [device adhesion issue].Narrative: this is a spontaneous report from a contactable consumer.This 64-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) at unknown frequency on (b)(6) 2017 for very bad arthritis in lower back and chronic pain all the time.Medical history included chronic back pain for 10 years and had bursitis in her left hip and was just hoping for some pain relief, stated she stopped going to the orthopedic because all they want to do was give her cortisone, patient also had mastectomy and breast cancer.Concomitant medications were none.Consumer purchased a two-pack box of thermacare heatwraps from her local pharmacy.The wrap came in a red box.She thought it said to wrap it around your back where your pain was.The box had 2 wraps that were not individually wrapped, there was no plastic or anything to open them up or anything, and they had 16 oval heat things inside.She used it yesterday and put it around her lower back, she didn't even leave it on 16 hours, thinks she left it on maybe 8.She went to take it off to maybe rewrap it and she touched her backside and it had made sores that were so bad that her skin was open and now there was 2 sores the size of the little ovals, one was worse than the other ((b)(6) 2017).She had to wash her body, put neosporin on there, and then a great big bandage to cover it.She was really upset about it because her skin was burnt.She had red marks all over her back.Added that if she would have left the wrap on for 16 hours, it might have made more sores.She had to keep readjusting it because it kept sliding, the one on her hip did not work because it kept sliding because you can't wrap it around your hip like that.So she put the second one higher up on her back, above the one on her lower back.The one on the lower back was the one that really screwed things up and she was really pissed off.She spoke to a nurse that was part of the company that helped provide help at her some and was advised to take a shower, put neosporin on it, and keep it dry.She wanted some compensation because it really hurt, that was not the way it was supposed to work.Added she was in a lot of pain and couldn't sleep last night on (b)(6) 2017, no treatment for couldn't sleep.Consumer stated this was a permanent stop of the product and that she won't buy anymore thermacare and maybe even pfizer products because it burnt the crap out of her back.A sample of the product was available to be returned.Consumer stated that she had pictures that she could send if needed.Consumer stated this happened on (b)(6) 2017.She called on 29aug2017.She went to the doctor twice and he ordered silvadene cream and a tetanus shot.She added that she was sent paperwork asking her to fill out.She did not have the box to provide ncd, lot or expiry.She went to pharmacy where she purchased it to try to get information.The product was in a (mailer service).She was planning on sending it back but had not yet.She could not find ncd, lot or expiry.She added they were 2 wraps in a red box.She asked the lady to clean her house to help her get it on.She tried to put around hips and legs.8 hours later she took it off and skin came off on her finger.She had already reported the burn.Adds that there were 16 ovals on the pack and you could see the ovals on her back.She emailed pictures of lower back side.It showed the 2 places where she was burned.She had the product on only for 8 hours.She was burned severely.It had cleared up since them.The patient was not hospitalized due to the events.The patient reported "i did not keep box once i put wrap on was in trash." the patient was not pregnant or post-menopausal.Skin tone was medium.The patient not have sensitive skin or abnormal skin conditions.The patient did not previously use other heat products for pain.The patient did not engage in exercise while using the product.The patient checked skin every 2 hrs under the product while wearing thermacare.The patient read the usage instructions on thermacare before used the product.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2017.The outcome of the events 2 open sores on lower back the size of the ovals on heat wrap and burn was not resolved.The outcome of the event couldn't sleep last night was recovered on unknown date in 2017.The outcome of the other events was unknown.Follow-up (09sep2017): new information from a contactable consumer includes: suspect product trade name.Follow-up (15sep2017): new information received from the same contactable consumer included: events details.Follow-up (19sep2017): new information received from a contactable consumer reported in response to non hcp letter included that: medical history, concomitant drug information, patient's information, event couldn't sleep last night onset date, patient hospitalization information, event treatment information and outcome.Follow-up (27sep2017): this contactable consumer reported by way of consumer questionnaire.This female patient used thermacare heatwrap (thermacare lower back and hip) on (b)(6) 2017 and she discontinued to use thermacare heatwrap after using it for approximately 8 hours on (b)(6) 2017.Alternatively it was reported that the patient used thermacare heat wrap for less than one day.On (b)(6) 2017, she directly applied the heat wrap to the skin around her base lower back and checked the skin frequently.After using thermacare she developed 16 red marks and 2 severe burns open sores.The wrap was not heated in microwave and neither re heated at all during usage.It was reported that she was under the medical care of a physician for burns.As of (b)(6) 2017, the clinical outcome of the event directly applied the heat wrap to the skin around her base lower back was unknown.Follow-up (30jul2020): new information received from the product quality complaint group includes investigational results: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number.Without a batch reference number 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 adhesion/fastening defect.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.Evaluation of the return sample does not provide evidence to support a defective product.Complaint cannot be confirmed.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Sample was received at the site on (b)(6) 2017.2 wraps- two wraps show evidence of wear.No obvious defects.No evidence to defect to the material.Reasonably suggest device malfunction was yes.Severity of harm was s1.Amendment: breast cancer added as medical history."put the second one higher up on her back, above the one on her lower back/put around hips and legs" subsumed under at risk event.Events "did not work" and "kept sliding" added.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed as a quality defect).This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number.Without a batch reference number 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 adhesion/fastening defect.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.Evaluation of the return sample does not provide evidence to support a defective product.Complaint cannot be confirmed.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Sample was received at the site on (b)(6) 2017.2 wraps- two wraps show evidence of wear.No obvious defects.No evidence to defect to the material.Reasonably suggest device malfunction was yes.Severity of harm was s1.
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Search Alerts/Recalls
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