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| Device Problems
Leak/Splash (1354); Material Integrity Problem (2978)
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| Patient Problems
Skin Erosion (2075); Burn, Thermal (2530); No Code Available (3191)
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| Event Date 05/01/2016 |
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Event Type
Injury
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Event Description
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Burned her skin, back was all red, burning and sore [thermal burn].Took a layer of skin off/little black things were all over her hands, arms, back, and neck [skin exfoliation].Wearing on shoulder blade [intentional device misuse].Feels like she might have breathed it in [feeling abnormal].The contents leaked out , it was everywhere, saw that the little black things were all over her hands, arms, back, and neck.[product quality issue].The contents leaked out [device leakage].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date once a week, and only one per day for pain.Medical history included ongoing copd (chronic obstructive pulmonary disease) diagnosed 13 years ago.The patient's concomitant medications were not reported.The patient experienced was wearing the thermacare lower back and hip, size small to medium, on her shoulder blade on (b)(6) 2016, stated that it was not under her bra strap.The contents leaked out and burned her skin and took a layer of skin off.She put the product on while at work.After about 2.5 hours, she started seeing little black things flying around.She joked with her co-workers that they were gnats, because she didn't know what they were and they felt funny when they landed on her arm.By the time she got home from work, her back was burning and sore, and she saw that the little black things were all over her hands, arms, back, and neck.She had to take a shower to get all the black stuff off.The redness on her back was just in the area where the patch was.States that the burn was underneath the patch, and it feels like it's about an inch long.It peeled like if she had gotten bad sunburn.She has not spoken with her primary care doctor about it, and has not done anything to treat it yet.She wanted to find out what was in the heat cells and what was safe to put on it first.She felt like she might have breathed some of it in because it was everywhere.This concerns her because she has copd.The packaging on the wrap was sealed, but it seemed like there was more in the bottom of that particular wrap than normal.No measure was taken for events burn and took a layer of skin off.The action taken of the product was unknown.The outcome of the event burn and took a layer of skin off was not recovered, 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 burn and skin exfoliation as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events of feeling abnormal intentional misuse, device leakage, feeling abnormal, and product quality issue are assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burn and skin exfoliation as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events of feeling abnormal intentional misuse, device leakage, feeling abnormal, and product quality issue are assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.
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Event Description
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Burned her skin, back was all red, burning and sore/had a chemical burn scar on back [thermal burn].Took a layer of skin off/little black things were all over her hands, arms, back, and neck/started seeing black spots on my arm [skin exfoliation].Wearing on shoulder blade/for what purpose was thermacare used: shoulder, neck pain [intentional device misuse].Feels like she might have breathed it in [feeling abnormal].The contents leaked out , it was everywhere, saw that the little black things were all over her hands, arms, back, and neck/ [product quality issue].The contents leaked out [device leakage].Redness at arms [erythema].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) years-old caucasian female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from (b)(6) 2016.Once a week, and only one per day for pain, back and shoulder/neck pain.Medical history included ongoing copd (chronic obstructive pulmonary disease) diagnosed 13 years ago, skin cancer on face and testing left arm.The patient's concomitant medications included levothyroxine sodium (synthroid).The patient started using the product on shoulder blade since (b)(6) 2016.She previously used the product and experienced redness at arms.The patient was wearing the thermacare lower back and hip, size small to medium, on her shoulder blade on (b)(6) 2016, stated that it was not under her bra strap.The contents leaked out and burned her skin and took a layer of skin off.She put the product on while at work.After about 2.5 hours, she started seeing little black things flying around.She joked with her co-workers that they were gnats, because she didn't know what they were and they felt funny when they landed on her arm.By the time she got home from work, her back was burning and sore, and she saw that the little black things were all over her hands, arms, back, and neck.She had to take a shower to get all the black stuff off.The redness on her back was just in the area where the patch was.States that the burn was underneath the patch, and it feels like it's about an inch long.It peeled like if she had gotten bad sunburn.Her shoulder really hurt.Large area red and burned.Area of about 1 and half to 2 m where skin was off applied cold compress.She wanted to find out what was in the heat cells and what was safe to put on it first.She felt like she might have breathed some of it in because it was everywhere.This concerns her because she has copd.The packaging on the wrap was sealed, but it seemed like there was more in the bottom of that particular wrap than normal.The patient went to dermatologist on (b)(6) 2016, he immediately noted that the patient had a chemical burn scar on back.The patient was admission to hospital due to the reported events.The patient skin tone is medium (neither light nor dark), she has no sensitive skin, no abnormal skin conditions.She previously used other heat products for pain relief, and experienced a problem/symptom with one of these products.She attached the adhesive to body, wore regular t-shirt.No engage in exercise while using the product, she checked skin under the product while wearing thermacare.Due to she was at work, it felt hotter but did not have time to check until she got home.She read the usage instructions on thermacare before used the product.It took skin about 5 days to heal.She had to cover with bandage so clothing couldn't touch her skin.Area was very sore where skin came off.The measure was taken for event took a layer of skin off included cool pad, for other events included antibiotic, for event feels like she might have breathed it included proventil.The action taken of the product was permanently withdrawn on (b)(6) 2016.The outcome of the event burn and took a layer of skin off was not recovered and the outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2016): new information reported from a contactable consumer in response to non-hcp letter sent that included: medical history, concomitant medication, product data (action taken and indication), new event (redness at arm), treatment, event serious criteria (admission to hospital) and detail.No follow-up attempts are possible.An investigation of the device could not be conducted.Company clinical evaluation comment based on the information provided, the events burn, skin exfoliation, feeling abnormal intentional misuse, device leakage, and product quality issue as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event erythema is assessed as associated with the device.This case meets follow up and final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burn, skin exfoliation, feeling abnormal intentional misuse, device leakage, and product quality issue as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event erythema is assessed as associated with the device.This case meets follow up and final 10-day eu and 30-day fda reportability.
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Event Description
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Burned her skin, back was all red, burning and sore/had a chemical.Burn scar on back [thermal burn].Took a layer of skin off/little black things were all over her hands, arms, back, and neck/started seeing black spots on my arm [skin exfoliation].Wearing on shoulder blade/for what purpose was thermacare used?: shoulder, neck pain [intentional device misuse].Feels like she might have breathed it in [feeling abnormal].The contents leaked out , it was everywhere, saw that the little black things were all over her hands, arms, back, and neck/ [product quality issue].The contents leaked out [device leakage].Redness at arms [erythema].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from (b)(6) 2016 once a week, and only one per day for pain, back and shoulder/neck pain.Medical history included ongoing copd (chronic obstructive pulmonary disease) diagnosed 13 years ago, skin cancer on face and testing left arm.The patient's concomitant medications included levothyroxine sodium (synthroid).The patient started using the product on shoulder blade since (b)(6) 2016.She previously used the product and experienced redness at arms.The patient was wearing the thermacare lower back and hip, size small to medium, on her shoulder blade on (b)(6) 2016, stated that it was not under her bra strap.The contents leaked out and burned her skin and took a layer of skin off.She put the product on while at work.After about 2.5 hours, she started seeing little black things flying around.She joked with her co-workers that they were gnats, because she didn't know what they were and they felt funny when they landed on her arm.By the time she got home from work, her back was burning and sore, and she saw that the little black things were all over her hands, arms, back, and neck.She had to take a shower to get all the black stuff off.The redness on her back was just in the area where the patch was.States that the burn was underneath the patch, and it feels like it's about an inch long.It peeled like if she had gotten bad sunburn.Her shoulder really hurt.Large area red and burned.Area of about 1 and half to 2 m where skin was off applied cold compress.She wanted to find out what was in the heat cells and what was safe to put on it first.She felt like she might have breathed some of it in because it was everywhere.This concerns her because she has copd.The packaging on the wrap was sealed, but it seemed like there was more in the bottom of that particular wrap than normal.The patient went to dermatologist on (b)(6) 2016, he immediately noted that the patient had a chemical burn scar on back.The patient was admission to hospital due to the reported events.The patient skin tone is medium (neither light nor dark), she has no sensitive skin, no abnormal skin conditions.She previously used other heat products for pain relief, and experienced a problem/symptom with one of these products.She attached the adhesive to body, wore regular t-shirt.No engage in exercise while using the product, she checked skin under the product while wearing thermacare.Due to she was at work, it felt hotter but did not have time to check until she got home.She read the usage instructions on thermacare before used the product.It took skin about 5 days to heal.She had to cover with bandage so clothing couldn't touch her skin.Area was very sore where skin came off.The measure was taken for event took a layer of skin off included cool pad, for other events included antibiotic, for event feels like she might have breathed it included proventil.The action taken of the product was permanently withdrawn on (b)(6) 2016.The outcome of the event burn and took a layer of skin off was not recovered and the outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (29jun2016): new information reported from a contactable consumer in response to non-hcp letter sent that included: medical history, concomitant medication, product data (action taken and indication), new event (redness at arm), treatment, event serious criteria (admission to hospital) and detail.No follow-up attempts are possible.An investigation of the device could not be conducted.Company clinical evaluation comment based on the information provided, the events burn, skin exfoliation, feeling abnormal intentional misuse, device leakage, and product quality issue as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event erythema is assessed as associated with the device.This case meets follow up and final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burn, skin exfoliation, feeling abnormal intentional misuse, device leakage, and product quality issue as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event erythema is assessed as associated with the device.This case meets follow up and final 10-day eu and 30-day fda reportability.
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Event Description
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Event verbatim [preferred term] burned her skin, back was all red, burning and sore/had a chemical burn scar on back [thermal burn], took a layer of skin off/little black things were all over her hands, arms, back, and neck/started seeing black spots on my arm [skin exfoliation] , wearing on shoulder blade/for what purpose was thermacare used?: shoulder, neck pain [intentional device misuse] , feels like she might have breathed it in [feeling abnormal] , the contents leaked out , it was everywhere, saw that the little black things were all over her hands, arms, back, and neck/ [product complaint] , the contents leaked out [device leakage] , redness at arms [erythema] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 67-years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from (b)(6) 2016 once a week, and only one per day for pain, back and shoulder/neck pain.Medical history included ongoing copd (chronic obstructive pulmonary disease) diagnosed 13 years before (in 2003), skin cancer on face and testing left arm.The patient's concomitant medications included levothyroxine sodium (synthroid).The patient started using the product on shoulder blade since (b)(6) 2016.She previously used the product and experienced redness at arms.The patient was wearing the thermacare lower back and hip, size small to medium, on her shoulder blade on (b)(6) 2016, stated that it was not under her bra strap.The contents leaked out and burned her skin and took a layer of skin off.She put the product on while at work.After about 2.5 hours, she started seeing little black things flying around.She joked with her co-workers that they were gnats, because she didn't know what they were and they felt funny when they landed on her arm.By the time she got home from work, her back was burning and sore, and she saw that the little black things were all over her hands, arms, back, and neck.She had to take a shower to get all the black stuff off.The redness on her back was just in the area where the patch was.States that the burn was underneath the patch, and it feels like it's about an inch long.It peeled like if she had gotten bad sunburn.Her shoulder really hurt.Large area red and burned.Area of about 1 and half to 2 m where skin was off applied cold compress.She wanted to find out what was in the heat cells and what was safe to put on it first.She felt like she might have breathed some of it in because it was everywhere.This concerns her because she had copd.The packaging on the wrap was sealed, but it seemed like there was more in the bottom of that particular wrap than normal.The patient went to dermatologist on (b)(6) 2016, he immediately noted that the patient had a chemical burn scar on back.The patient was admission to hospital in 2016 due to the reported events expect redness at arms.The patient skin tone is medium (neither light nor dark), she has no sensitive skin, no abnormal skin conditions.She previously used other heat products for pain relief and experienced a problem/symptom with one of these products.She attached the adhesive to body, wore regular t-shirt.No engage in exercise while using the product, she checked skin under the product while wearing thermacare.Due to she was at work, it felt hotter but did not have time to check until she got home.She read the usage instructions on thermacare before used the product.It took skin about 5 days to heal.She had to cover with bandage so clothing couldn't touch her skin.Area was very sore where skin came off.The measure was taken for event took a layer of skin off included cool pad, for other events included antibiotic, for event feels like she might have breathed it included proventil.The action taken of the product was permanently withdrawn on 15may2016.The outcome of the event 'redness at arms' was unknown; the outcome of 'burned her skin, back was all red, burning and sore/had a chemical burn scar on back' and 'took a layer of skin off/little black things were all over her hands, arms, back, and neck/started seeing black spots on my arm' was resolved on (b)(6) 2016, of all other reported events was recovered in 2016.According to product quality complaint: reasonably suggest device malfunction was yes and severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Follow-up (29jun2016): new information reported from a contactable consumer in response to non-hcp letter sent that included: medical history, concomitant medication, product data (action taken and indication), new event (redness at arm), treatment, event serious criteria (admission to hospital) and detail.No follow-up attempts are possible.No further information is expected.Follow-up (13feb2020): new information received from a product quality complaint group includes: manufacturing site severity and malfunction assessment provided.Company clinical evaluation comment: based on the information provided, the events burn, skin exfoliation, feeling abnormal intentional misuse, device leakage, and product quality issue as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event erythema is assessed as associated with the device.This case meets follow up and final 10-day eu and 30-day fda reportability., comment: based on the information provided, the events burn, skin exfoliation, feeling abnormal intentional misuse, device leakage, and product quality issue as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event erythema is assessed as associated with the device.This case meets follow up and final 10-day eu and 30-day fda reportability.
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Event Description
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Burned her skin, back was all red, burning and sore/had a chemical burn scar on back [thermal burn], took a layer of skin off/little black things were all over her hands, arms, back, and neck/started seeing black spots on my arm [skin exfoliation], wearing on shoulder blade/for what purpose was thermacare used?: shoulder, neck pain [intentional device misuse], feels like she might have breathed it in [feeling abnormal], the contents leaked out , it was everywhere, saw that the little black things were all over her hands, arms, back, and neck/ [product complaint], the contents leaked out [device leakage], redness at arms [erythema].Case description: this is a spontaneous report from a contactable consumer.A 67-years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from (b)(6) 2016 once a week, and only one per day for pain, back and shoulder/neck pain.Medical history included ongoing copd (chronic obstructive pulmonary disease) diagnosed 13 years before (in 2003), skin cancer on face and testing left arm.The patient's concomitant medications included levothyroxine sodium (synthroid).The patient started using the product on shoulder blade since (b)(6) 2016.She previously used the product and experienced redness at arms.The patient was wearing the thermacare lower back and hip, size small to medium, on her shoulder blade on (b)(6) 2016, stated that it was not under her bra strap.The contents leaked out and burned her skin and took a layer of skin off.She put the product on while at work.After about 2.5 hours, she started seeing little black things flying around.She joked with her co-workers that they were gnats, because she didn't know what they were and they felt funny when they landed on her arm.By the time she got home from work, her back was burning and sore, and she saw that the little black things were all over her hands, arms, back, and neck.She had to take a shower to get all the black stuff off.The redness on her back was just in the area where the patch was.States that the burn was underneath the patch, and it feels like it's about an inch long.It peeled like if she had gotten bad sunburn.Her shoulder really hurt.Large area red and burned.Area of about 1 and half to 2 m where skin was off applied cold compress.She wanted to find out what was in the heat cells and what was safe to put on it first.She felt like she might have breathed some of it in because it was everywhere.This concerns her because she had copd.The packaging on the wrap was sealed, but it seemed like there was more in the bottom of that particular wrap than normal.The patient went to dermatologist on (b)(6) 2016, he immediately noted that the patient had a chemical burn scar on back.The patient was admission to hospital in 2016 due to the reported events except redness at arms.The patient skin tone is medium (neither light nor dark), she has no sensitive skin, no abnormal skin conditions.She previously used other heat products for pain relief and experienced a problem/symptom with one of these products.She attached the adhesive to body, wore regular t-shirt.No engage in exercise while using the product, she checked skin under the product while wearing thermacare.Due to she was at work, it felt hotter but did not have time to check until she got home.She read the usage instructions on thermacare before used the product.It took skin about 5 days to heal.She had to cover with bandage so clothing couldn't touch her skin.Area was very sore where skin came off.Therapeutic measure was taken for event took a layer of skin off included cool pad, for other events included antibiotic, for event feels like she might have breathed it included proventil.The consumer discarded the wrap and the packaging.A sample of the product is not available to be returned.The action taken of the product was permanently withdrawn on 15may2016.The outcome of the event 'redness at arms' was unknown; the outcome of 'burned her skin, back was all red, burning and sore/had a chemical burn scar on back' and 'took a layer of skin off/little black things were all over her hands, arms, back, and neck/started seeing black spots on my arm' was resolved on (b)(6) 2016, of all other reported events was recovered in 2016.According to product quality complaint: reasonably suggest device malfunction was yes and severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Follow-up (29jun2016): new information reported from a contactable consumer in response to non-hcp letter sent that included: medical history, concomitant medication, product data (action taken and indication), new event (redness at arm), treatment, event serious criteria (admission to hospital) and detail.No follow-up attempts are possible.No further information is expected.Follow-up (13feb2020): new information received from a product quality complaint group includes: manufacturing site severity and malfunction assessment provided.Follow-up (14feb2020): new information received from the product quality complaint group included sample of the product is not available to be returned.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 cells damaged/leaking.The most probable root cause of this event is equipment/mechanical failure.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 cells damaged/leaking.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.Site sample status: not received.
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Event Description
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Event verbatim [preferred term] burned her skin, back was all red, burning and sore/had a chemical burn scar on back [thermal burn] , took a layer of skin off/little black things were all over her hands, arms, back, and neck/started seeing black spots on my arm [skin exfoliation] , the contents leaked out [device leakage] , wearing on shoulder blade/for what purpose was thermacare used?: shoulder, neck pain [intentional device misuse] , feels like she might have breathed it in [feeling abnormal] , redness at arms [erythema].Case narrative:this is a spontaneous report from a contactable consumer.A 67-years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from (b)(6) 2016 once a week, and only one per day for pain, back and shoulder/neck pain.Medical history included ongoing copd (chronic obstructive pulmonary disease) diagnosed 13 years before (in 2003), skin cancer on face and testing left arm.The patient's concomitant medications included levothyroxine sodium (synthroid).The patient started using the product on shoulder blade since (b)(6) 2016.She previously used the product and experienced redness at arms.The patient was wearing the thermacare lower back and hip, size small to medium, on her shoulder blade on (b)(6) 2016, stated that it was not under her bra strap.The contents leaked out and burned her skin and took a layer of skin off.She put the product on while at work.After about 2.5 hours, she started seeing little black things flying around.She joked with her co-workers that they were gnats, because she didn't know what they were and they felt funny when they landed on her arm.By the time she got home from work, her back was burning and sore, and she saw that the little black things were all over her hands, arms, back, and neck.She had to take a shower to get all the black stuff off.The redness on her back was just in the area where the patch was.States that the burn was underneath the patch, and it feels like it's about an inch long.It peeled like if she had gotten bad sunburn.Her shoulder really hurt.Large area red and burned.Area of about 1 and half to 2 m where skin was off applied cold compress.She wanted to find out what was in the heat cells and what was safe to put on it first.She felt like she might have breathed some of it in because it was everywhere.This concerns her because she had copd.The packaging on the wrap was sealed, but it seemed like there was more in the bottom of that particular wrap than normal.The patient went to dermatologist on (b)(6) 2016, he immediately noted that the patient had a chemical burn scar on back.The patient was admission to hospital in 2016 due to the reported events except redness at arms.The patient skin tone is medium (neither light nor dark), she has no sensitive skin, no abnormal skin conditions.She previously used other heat products for pain relief and experienced a problem/symptom with one of these products.She attached the adhesive to body, wore regular t-shirt.No engage in exercise while using the product, she checked skin under the product while wearing thermacare.Due to she was at work, it felt hotter but did not have time to check until she got home.She read the usage instructions on thermacare before used the product.It took skin about 5 days to heal.She had to cover with bandage so clothing couldn't touch her skin.Area was very sore where skin came off.Therapeutic measure was taken for event took a layer of skin off included cool pad, for other events included antibiotic, for event feels like she might have breathed it included proventil.The consumer discarded the wrap and the packaging.A sample of the product is not available to be returned.The action taken of the product was permanently withdrawn on (b)(6) 2016.The outcome of the event 'redness at arms' was unknown; the outcome of 'burned her skin, back was all red, burning and sore/had a chemical burn scar on back' and 'took a layer of skin off/little black things were all over her hands, arms, back, and neck/started seeing black spots on my arm' was resolved on (b)(6) 2016, of all other reported events was recovered in 2016.According to product quality complaint: reasonably suggest device malfunction was yes and severity of harm was s3.Additional information includes: summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 cells damaged/leaking.The most probable root cause of this event is equipment/mechanical failure.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 cells damaged/leaking.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.Site sample status: not received.Follow-up (29jun2016): new information reported from a contactable consumer in response to non-hcp letter sent that included: medical history, concomitant medication, product data (action taken and indication), new event (redness at arm), treatment, event serious criteria (admission to hospital) and detail.No follow-up attempts are possible.No further information is expected.Follow-up (13feb2020): new information received from a product quality complaint group includes: manufacturing site severity and malfunction assessment provided.Follow-up (14feb2020): new information received from the product quality complaint group included sample of the product is not available to be returned.Follow-up attempts are completed.No further information is expected.Follow-up (18feb2020): new information received from the product quality complaint group included investigation summary, comment: based on the information provided, the events thermal burn, skin exfoliation, feeling abnormal, intentional device misuse, and device leakage as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event erythema is assessed as associated with the device.This case meets follow up and final 10-day eu and 30-day fda reportability.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Search Alerts/Recalls
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