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| Lot Number 3700034563 |
| Device Problems
Use of Device Problem (1670); Insufficient Information (3190)
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| Patient Problems
Itching Sensation (1943); Rash (2033); Scarring (2061); Disability (2371); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
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| Event Date 06/14/2015 |
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Event Type
Injury
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Event Description
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Severe burns and blisters that were across her back and above her waist [thermal burn].Severe burns and blisters that were across her back and above her waist [blister].She has a rash that was itching [rash pruritic].She was unable to do the things that she normally used to do, she could not go to the store, market [activities of daily living impaired].She had some scars [scar].Case description: this is a spontaneous report from a contactable consumer or other non hcp.An (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back and hip) (lot # as reported as 3700034563) from an unspecified date in (b)(6) 2015 (reported as 2 or 3 weeks ago) at 1 heatwrap 1 time for at least 6 hours for an unspecified back problem.The patient's medical history was not reported.Concomitant medication included tamoxifen (tamoxifen), losartan potassium (cozaar) and simvastatin (simvastatin).On an unspecified date in (b)(6) 2015, the patient reported she used 1 heatwrap for only 1 time for 1 evening for an unspecified back problem for which she was seeing a physical therapist.She put the heatwrap on for at least 6 hours and experienced severe burns and blisters that were across her back and above her waist.The patient reported she had gone to a medical doctor (md) who confirmed her blisters on her back.She mentioned she did not know the degree of the burns because she was putting cortisone on the area and could only see the burns in a mirror.The patient stated she had pain and a rash that was itching.She mentioned she was unable to do the things that she normally used to do like go for her physical therapy appointment, go to the store or market and could not go for dinner.She reported right not she had some scars.The patient thought the heatwrap was warm but she did not think it was burning her skin.The patient assessed her skin tone as medium.She did not use any creams, rubs, or gels under the wrap.The patient had never used the thermacare heatwraps in the past.She confirmed there were not cuts, tears, leaks or holes in the wrap.The patient did not change or modify the wrap in anyway and did not use the wrap overnight or while sleeping.She did not put the wrap in the microwave and did not exercise while using the heatwrap.The patient used the heatwrap over healthy, normal skin.She did not apply any pressure over the wrap and did not remember if she had worn more than 2 layers of clothing over the wrap.The patient sat while using the wrap and might have gotten up to do a couple of things but she was primarily quiet.She had not used more than 1 wrap daily and still had the other unused heatwrap in the box.The patient was not suffering from any medical conditions like diabetes or high blood pressure.The patient had not undergone any lab work related to her burns.Action taken with the suspect product was permanently withdrawn on an unspecified date in (b)(6) 2015.Therapeutic measures rec'd included cortisone at an unspecified dose and frequency from an unspecified date in (b)(6) 2015 and unk if ongoing.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.
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Manufacturer Narrative
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Company clinical evaluation comment: based on the information provided, the events "burn and blister" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer or other non hcp.An (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare lower back & hip) (lot # reported as 3700034563) from an unspecified date in (b)(6) 2015 (reported as 2 or 3 weeks ago) at 1 heatwrap 1 time for at least 6 hours for an unspecified back problem.The patient's medical history was not reported.Concomitant medication included tamoxifen (tamoxifen), losartan potassium (cozaar) and simvastatin (simvastatin).On an unspecified date in (b)(6) 2015, the patient reported she used 1 heatwrap for only 1 time for 1 evening for an unspecified back problem for which she was seeing a physical therapist.She put the heatwrap on for at least 6 hours and experienced severe burns and blisters that were across her back and above her waist.The patient reported she had gone to a medical doctor (md) who confirmed her blisters on her back.She mentioned she did not know the degree of the burns because she was putting cortisone on the area and could only see the burns in a mirror.The patient stated she had pain and a rash that was itching.She mentioned she was unable to do the things that she normally used to do like go for her physical therapy appointment, go to the store or market and could not go for dinner.She reported right now she had some scars.The patient thought the heatwrap was warm but she did not think it was burning her skin.The patient assessed her skin tone as medium.She did not use any creams, rubs or gels under the wrap.The patient had never used the thermacare heatwraps in the past.She confirmed there were no cuts, tears, leaks or holes in the wrap.The patient did not change or modify the wrap in anyway and did not use the wrap overnight or while sleeping.She did not put the wrap in the microwave and did not exercise while using the heatwrap.The patient used the heatwrap over healthy, normal skin.She did not apply any pressure over the wrap and did not remember if she had worn more than 2 layers of clothing over the wrap.The patient sat while using the wrap and might have gotten up to do couple of things but she was primarily quiet.She had not used more than 1 wrap daily and still had the other unused heatwrap in the box.The patient was not suffering from any medical conditions like diabetes or high blood pressure.The patient had not undergone any lab work related to her burns.Action taken with the suspect product was permanently withdrawn on an unspecified date in (b)(6) 2015.Therapeutic measures received included cortisone at an unspecified dose and frequency from an unspecified date in (b)(6) 2015 and unknown if ongoing.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (20jul2015): this contactable consumer reported by way of claim letter.This female patient placed a thermacare heat wrap (thermacare lower back & hip) on her back for few days.In (b)(6) 2015, upon evaluation her thoracic muscles were covered with blisters and she experienced severe pain after she took the pad off.As of (b)(6) 2015, the clinical outcome of the event severe pain was unknown.Follow-up (03aug2015): this is a follow-up report combining information from duplicate reports ((b)(4)) and ((b)(4)).The current and subsequent information will be reported under manufacturer report number ((b)(4)).The new information reported from a contactable consumer included that this female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), (reported as thermacare pain relief for muscle relaxation) on an unknown date for an unknown indication.She started to receive thermacare heatwrap (thermacare lower back & hip) (expiration date was reported as aug2004) for sore back.The concomitant medication included tamoxifen, losartan (cozaar) and simvastatin daily since an unknown date.On (b)(6) 2015, she experienced severe burns and blisters that were across her back and above her waist, she has a rash that was itching, she was unable to do the things that she normally used to do, she could not go to the store, market, she got terrible itch after the burn, she had pain from the burns and she had some scars and these conditions were reported as still experiencing.She was recommended physical exercise on an unknown date.She had self care with cortisone ointment daily since an unknown date, benadryl ointment and applied an unknown cream on an unknown date for severe burns and blisters that were across her back and above her waist, rash that was itching, unable to do the things that she normally used to do, she could not go to the store, market, terrible itch after the burn, pain from the burns and some scars.As of (b)(6) 2015, the clinical outcome of events was not recovered.Follow-up (20aug2015): this contactable consumer reported by a way of consumer questionnaire and claim letter.On (b)(6) 2015, she used thermacare heatwrap (thermacare lower back & hip) as per instructions on her lower back (directly to skin).She stopped using thermacare heatwrap on same date.On (b)(6) 2015, she started self medication, over the counter hydrocortisone cream for her burns and blisters.It was reported that, she was unable to do normal physical therapy.
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Event Description
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Severe burns and blisters that were across her back and above her waist (thermal burn).Severe burns and blisters that were across her back and above her waist (blister).She has a rash that was itching (rash pruritic).She was unable to do the things that she normally used to do, she could not go to the store, market (mobility decreased).She had some scars (scar).She had pain from the burns (pain).This is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back and hip) (lot #reported as (b)(4)) from an unspecified date in (b)(6) 2015 (reported as 2 or 3 weeks ago) as 1 heatwrap 1 time for at least 6 hours for an unspecified back problem.Follow-up ((b)(6) 2015): this contactable consumer reported by way of claim letter.This female patient placed a thermacare heat wrap (thermacare lower back and hip) on her back for a few days.In (b)(6) 2015, upon evaluation her thoracic muscles were covered with blisters and she experienced severe pain after she took the pad off.As of (b)(6) 2015, the clinical outcome of the event severe pain was unk.Follow-up (08/03/2015): this is a follow-up report combining information from duplicate reports (b)(4).The current and subsequent information will be reported under mfr report number ((b)(4)).The new information reported from a contactable consumer included that this female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), (reported as thermacare pain relief for muscle relaxation) on an unk date for an indication.She started to receive thermacare heatwrap (thermacare lower back and hip) (expiration date was reported as august 2004) for sore back.The concomitant medication included tamoxifen, losartan (cozaar) and simvastatin daily since an unk date.On (b)(6) 2015, she experienced severe burns and blisters that were across her back and above her waist, she has a rash that was itching, she was unable to do the things that she normally used to do, she could not go to the store, market, she got terrible itch after the burn, she had pain from the burns and she had some scars and these conditions were reported as still experiencing.She was recommended physical exercise on an unk date.She had self care with cortisone ointment daily since an unk date, benadryl ointment and applied an unk cream on an unk date for severe burns and blisters that were across her back and above her waist, rash that was itching, unable to do the things that she normally used to do, she could not go to the store, market, terrible itch after the burn, pain from the burns and some scars.As of (b)(4) 2015, the clinical outcome of events was not recovered.
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Manufacturer Narrative
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This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 available for evaluation.A manufacturing and technical assessment not complete for the wrap involved in this case due to an unspecified batch reference number.No product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures, which include in-process testing and visual inspection, to ensure product quality.Lot trend assessment and rationale: no lot trending performed on unknown lot numbers.Site sample status was not received.
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Event Description
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Event verbatim [preferred term] severe burns and blisters that were across her back and above her waist/ she had pain from the burns [burns second degree], she used thermacare heatwrap (thermacare lower back & hip) as per instructions on her lower back (directly to skin).[device use error], she has a rash that was itching [rash pruritic], she was unable to do the things that she normally used to do, she could not go to the store, market [mobility decreased], she had some scars [scar], expiration date was reported as aug2004 [expired device used].Narrative: this is a spontaneous report from a contactable consumer.An 83-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) (lot # reported as 3700034563) from an unspecified date in (b)(6) 2015 (reported as 2 or 3 weeks ago) at 1 heatwrap 1 time for at least 6 hours for an unspecified back problem.The patient's medical history was not reported.Concomitant medication included tamoxifen (tamoxifen), losartan potassium (cozaar) and simvastatin (simvastatin).On an unspecified date in (b)(6) 2015, the patient reported she used 1 heatwrap for only 1 time for 1 evening for an unspecified back problem for which she was seeing a physical therapist.She put the heatwrap on for at least 6 hours and experienced severe burns and blisters that were across her back and above her waist.The patient reported she had gone to a medical doctor (md) who confirmed her blisters on her back.She mentioned she did not know the degree of the burns because she was putting cortisone on the area and could only see the burns in a mirror.The patient stated she had pain and a rash that was itching.She mentioned she was unable to do the things that she normally used to do like go for her physical therapy appointment, go to the store or market and could not go for dinner.She reported right now she had some scars.The patient thought the heatwrap was warm but she did not think it was burning her skin.The patient assessed her skin tone as medium.She did not use any creams, rubs or gels under the wrap.The patient had never used the thermacare heatwraps in the past.She confirmed there were no cuts, tears, leaks or holes in the wrap.The patient did not change or modify the wrap in anyway and did not use the wrap overnight or while sleeping.She did not put the wrap in the microwave and did not exercise while using the heatwrap.The patient used the heatwrap over healthy, normal skin.She did not apply any pressure over the wrap and did not remember if she had worn more than 2 layers of clothing over the wrap.The patient sat while using the wrap and might have gotten up to do couple of things but she was primarily quiet.She had not used more than 1 wrap daily and still had the other unused heatwrap in the box.The patient was not suffering from any medical conditions like diabetes or high blood pressure.The patient had not undergone any lab work related to her burns.Action taken with the suspect\ product was permanently withdrawn on an unspecified date in (b)(6) 2015.Therapeutic measures received included cortisone at an unspecified dose and frequency from an unspecified date in (b)(6) 2015 and unknown if ongoing.Clinical outcome of the events was not resolved.Follow-up (20jul2015): this contactable consumer reported by way of claim letter.This female patient placed a thermacare heatwrap (thermacare lower back & hip) on her back for few days.In (b)(6) 2015, upon evaluation her thoracic muscles were covered with blisters and she experienced severe pain after she took the pad off.As of (b)(6) 2015, the clinical outcome of the event severe pain was unknown.Follow-up (20aug2015): this contactable consumer reported by a way of consumer questionnaire and claim letter.On (b)(6) 2015, she used thermacare heatwrap (thermacare lower back & hip) as per instructions on her lower back (directly to skin).She stopped using thermacare heatwrap on same date.On (b)(6) 2015, she started self medication, over the counter hydrocortisone cream for her burns and blisters.It was reported that, she was unable to do normal physical therapy.Follow-up (20apr2020): new information received from a product quality complaint group included: investigation result.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 available for evaluation.A manufacturing and technical assessment not complete for the wrap involved in this case due to an unspecified batch reference number.No product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures, which include in-process testing and visual inspection, to ensure product quality.Lot trend assessment and rationale: no lot trending performed on unknown lot numbers.Site sample status was not received.This follow-up report is also being submitted to amend previously reported information: reports (b)(4) and (b)(4) are reported for two different patients, and should not be processed as duplicate reports; information from (b)(4) (including suspect product thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain)) is removed from this report (b)(4) and will be reported under manufacturer report number (b)(4).Event 'she used thermacare heatwrap (thermacare lower back & hip) as per instructions on her lower back (directly to skin)' and 'expiration date was reported as aug2004' added, the outcome of both events was unknown; event ' severe burns and blisters that were across her back and above her waist' and 'she had pain from the burns' subsumed and coded as burn blister.Follow-up (05jun2020): this is a follow-up report to notify us food and drug administration (fda) that mfr report number 1066015-2015-00104.Mfr report number 1066015- 2015-00104 is to be considered as deleted.
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Manufacturer Narrative
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This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 available for evaluation.A manufacturing and technical assessment not complete for the wrap involved in this case due to an unspecified batch reference number.No product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures, which include in-process testing and visual inspection, to ensure product quality.Lot trend assessment and rationale: no lot trending performed on unknown lot numbers.Site sample status was not received.
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Event Description
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Event verbatim [preferred term] severe burns and blisters that were across her back and above her waist/ she had pain from the burns [burns second degree], she used thermacare heatwrap (thermacare lower back & hip) as per instructions on her lower back (directly to skin).[device use error], she has a rash that was itching [rash pruritic], she was unable to do the things that she normally used to do, she could not go to the store, market [mobility decreased], she had some scars [scar], expiration date was reported as aug2004 [expired device used].Narrative:
this is a spontaneous report from a contactable consumer.An 83-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) (lot # reported as 3700034563) from an unspecified date in (b)(6) 2015 (reported as 2 or 3 weeks ago) at 1 heatwrap 1 time for at least 6 hours for an unspecified back problem.The patient's medical history was not reported.Concomitant medication included tamoxifen (tamoxifen), losartan potassium (cozaar) and simvastatin (simvastatin).On an unspecified date in (b)(6) 2015, the patient reported she used 1 heatwrap for only 1 time for 1 evening for an unspecified back problem for which she was seeing a physical therapist.She put the heatwrap on for at least 6 hours and experienced severe burns and blisters that were across her back and above her waist.The patient reported she had gone to a medical doctor (md) who confirmed her blisters on her back.She mentioned she did not know the degree of the burns because she was putting cortisone on the area and could only see the burns in a mirror.The patient stated she had pain and a rash that was itching.She mentioned she was unable to do the things that she normally used to do like go for her physical therapy appointment, go to the store or market and could not go for dinner.She reported right now she had some scars.The patient thought the heatwrap was warm but she did not think it was burning her skin.The patient assessed her skin tone as medium.She did not use any creams, rubs or gels under the wrap.The patient had never used the thermacare heatwraps in the past.She confirmed there were no cuts, tears, leaks or holes in the wrap.The patient did not change or modify the wrap in anyway and did not use the wrap overnight or while sleeping.She did not put the wrap in the microwave and did not exercise while using the heatwrap.The patient used the heatwrap over healthy, normal skin.She did not apply any pressure over the wrap and did not remember if she had worn more than 2 layers of clothing over the wrap.The patient sat while using the wrap and might have gotten up to do couple of things but she was primarily quiet.She had not used more than 1 wrap daily and still had the other unused heatwrap in the box.The patient was not suffering from any medical conditions like diabetes or high blood pressure.The patient had not undergone any lab work related to her burns.Action taken with the suspect product was permanently withdrawn on an unspecified date in (b)(6) 2015.Therapeutic measures received included cortisone at an unspecified dose and frequency from an unspecified date in (b)(6) 2015 and unknown if ongoing.Clinical outcome of the events was not resolved.Follow-up (20jul2015): this contactable consumer reported by way of claim letter.This female patient placed a thermacare heat wrap (thermacare lower back & hip) on her back for few days.In (b)(6) 2015, upon evaluation her thoracic muscles were covered with blisters and she experienced severe pain after she took the pad off.As of (b)(6) 2015, the clinical outcome of the event severe pain was unknown.Follow-up (03aug2015): this is a follow-up report combining information from duplicate reports (b)(4).The current and subsequent information will be reported under manufacturer report number (b)(4).The new information reported from a contactable consumer included that this female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), (reported as thermacare pain relief for muscle relaxation) on an unknown date for an unknown indication.She started to receive thermacare heatwrap (thermacare lower back & hip) (expiration date was reported as aug2004) for sore back.The concomitant medication included tamoxifen, losartan (cozaar) and simvastatin daily since an unknown date.On (b)(6) 2015, she experienced severe burns and blisters that were across her back and above her waist, she has a rash that was itching, she was unable to do the things that she normally used to do, she could not go to the store, market, she got terrible itch after the burn, she had pain from the burns and she had some scars and these conditions were reported as still experiencing.She was recommended physical exercise on an unknown date.She had self care with cortisone ointment daily since an unknown date, benadryl ointment and applied an unknown cream on an unknown date for severe burns and blisters that were across her back and above her waist, rash that was itching, unable to do the things that she normally used to do, she could not go to the store, market, terrible itch after the burn, pain from the burns and some scars.As of (b)(6) 2015, the clinical outcome of events was not recovered.Follow-up (20aug2015): this contactable consumer reported by a way of consumer questionnaire and claim letter.On (b)(6) 2015, she used thermacare heatwrap (thermacare lower back & hip) as per instructions on her lower back (directly to skin).She stopped using thermacare heatwrap on same date.On (b)(6) 2015, she started self medication, over the counter hydrocortisone cream for her burns and blisters.It was reported that, she was unable to do normal physical therapy.Follow-up (20apr2020): new information received from a product quality complaint group included: investigation result.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 available for evaluation.A manufacturing and technical assessment not complete for the wrap involved in this case due to an unspecified batch reference number.No product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures, which include in-process testing and visual inspection, to ensure product quality.Lot trend assessment and rationale: no lot trending performed on unknown lot numbers.Site sample status was not received.This follow-up report is also being submitted to amend previously reported information: reports (b)(4) are reported for two different patients, and should not be processed as duplicate reports; information from (b)(4) (including suspect product thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain)) is removed from this report ((b)(4)) and will be reported under manufacturer report number ((b)(4)).Event 'she used thermacare heatwrap (thermacare lower back & hip) as per instructions on her lower back (directly to skin)' and 'expiration date was reported as aug2004' added, the outcome of both events was unknown; event ' severe burns and blisters that were across her back and above her waist' and 'she had pain from the burns' subsumed and coded as burn blister.
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Search Alerts/Recalls
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