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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erythema (1840); Tissue Damage (2104); Discharge (2225); Discomfort (2330); Full thickness (Third Degree) Burn (2696)
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| Event Date 04/01/2017 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] third degree burns/ her back was red and pink/blisters [burns third degree], her back was red and pink and small portion of her skin was removed [skin exfoliation], thermacare aggravated the blisters; it looks like shingles [condition aggravated], there appears to be some drainage [wound drainage], experiencing discomfort [discomfort], thermacare aggravated the blisters; it looks like shingles [(b)(6)].Case narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6) black female patient started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration on (b)(6) 2017 for lower back pain and hip pain.Medical history included atrial fibrillation, muscle relaxant therapy, palpitations, shingles, heart disease, slow pulse rate.Concomitant medications included ongoing tizanidine as muscle relaxant, flecainide began a couple of years ago and ongoing for palpitations, and furosemide began about 2 years ago (2015) and ongoing for her heart.She did not use thermacare previously.She previously used other heat products (a moist heating pad) for pain relief.Consumer used the thermacare product maybe 3 hours and received 3rd degree burns on (b)(6) 2017.She did not feel like it was burning while she had the wrap on, but when she removed it, her back was red and pink and small portion of her skin was removed on (b)(6) 2017.She was still experiencing discomfort in (b)(6) 2017 and it was hard to put clothes up against it.She had a bandage on it with some neosporin.She saw an internal medicine doctor (b)(6) 2017 who told her it looked like shingles and that the thermacare aggravated the blisters.The doctor gave her pain pills and something for shingles (the prescription was for 1g use 3 times a day), but she was not going to take the product.She has had shingles before and kept up with her vaccines.She did not think it looked like shingles.There appeared to be some drainage in (b)(6) 2017, but the burn area was still pink and the skin was off.She had a picture to send in.She stated that the doctor put a light with heat (like a lamp) to her back to examine it.There were no other investigations.She was currently under the care of pain management and cardiologist for atrial fibrillation.She classified her skin tone as medium.She did not have sensitive skin.She did not have abnormal skin conditions.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of third degree burns 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 reported events burn third degree, skin exfoliation, condition aggravated, and wound drainage as described in this case are considered serious bodily injuries/unanticipated serious deterioration requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event discomfort is considered associated with the device.The event shingles is considered as not associated with the device.Comment: based on the information provided, the reported events burn third degree, skin exfoliation, condition aggravated, and wound drainage as described in this case are considered serious bodily injuries/unanticipated serious deterioration requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event discomfort is considered associated with the device.The event shingles is considered as not associated with the device.
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Event Description
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Event verbatim [preferred term] third degree burns/ her back was red and pink/blisters [burns third degree], her back was red and pink and small portion of her skin was removed [skin exfoliation], thermacare aggravated the blisters; it looks like shingles [condition aggravated], there appears to be some drainage [wound drainage] , experiencing discomfort [discomfort], thermacare aggravated the blisters; it looks like shingles [(b)(6)].Case narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6) black female patient started to use thermacare heatwrap (thermacare lower back & hip), (device lot # not available), on (b)(6) 2017 for lower back pain and hip pain.Medical history included atrial fibrillation, muscle relaxant therapy, palpitations, shingles, heart disease, slow pulse rate.Concomitant medications included ongoing tizanidine 2 mg as needed as muscle relaxant, flecainide 50 mg 1x/day began a couple of years ago and ongoing for palpitations, and furosemide 20 mg 1x/day began about 2 years ago (2015) and ongoing for her heart.She did not use thermacare previously.She previously used other heat products (a moist heating pad) for pain relief.Consumer used the thermacare product maybe 3 hours and received 3rd degree burns on (b)(6) 2017.She did not feel like it was burning while she had the wrap on, but when she removed it, her back was red and pink and small portion of her skin was removed on (b)(6) 2017.She was still experiencing discomfort in (b)(6) 2017 and it was hard to put clothes up against it.She had a bandage on it with some neosporin.She saw an internal medicine doctor (b)(6) 2017 who told her it looked like shingles and that the thermacare aggravated the blisters.The doctor gave her pain pills and something for shingles (the prescription was for 1g use 3 times a day), but she was not going to take the product.She has had shingles before and kept up with her vaccines.She did not think it looked like shingles.There appeared to be some drainage in (b)(6) 2017, but the burn area was still pink and the skin was off.She had a picture to send in.She stated that the doctor put a light with heat (like a lamp) to her back to examine it.There were no other investigations.She was currently under the care of pain management and cardiologist for atrial fibrillation.She classified her skin tone as medium.She did not have sensitive skin.She did not have abnormal skin conditions.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of third degree burns 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 (12may2017): new information received from a contactable physician included the patient did not provide any information regarding the reported events with the use of the product.This follow-up is being submitted to notify that an investigation of the device cannot be conducted.Follow-up attempts have been completed and no further information is expected.Company clinical evaluation comment: based on the information provided, the reported events burn third degree, skin exfoliation, condition aggravated, and wound drainage as described in this case are considered serious bodily injuries/unanticipated serious deterioration requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event discomfort is considered associated with the device.The event shingles is considered as not associated with the device.Comment: based on the information provided, the reported events burn third degree, skin exfoliation, condition aggravated, and wound drainage as described in this case are considered serious bodily injuries/unanticipated serious deterioration requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event discomfort is considered associated with the device.The event shingles is considered as not associated with the device.
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Manufacturer Narrative
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Site sample status was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.Lot trend assessment and rationale was as a lot trend was not performed as the lot number is unknown.Conclusion was as follows 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, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.
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Event Description
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Third degree burns/ her back was red and pink/blisters [burns third degree], her back was red and pink and small portion of her skin was removed [skin exfoliation], thermacare aggravated the blisters; it looks like shingles [condition aggravated], experiencing discomfort [discomfort].Narrative: this is a spontaneous report from a contactable consumer (patient).A 69-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), (device lot # not available), on (b)(6) 2017 for lower back pain and hip pain.Medical history included afib (atrial fibrillation), muscle relaxant therapy, palpitations, shingles, heart disease, slow pulse rate.Concomitant medications included ongoing tizanidine 2 mg as needed as muscle relaxant, flecainide 50 mg once a day began a couple of years ago and ongoing for palpitations, and furosemide 20 mg once a day began about 2 years ago (2015) and ongoing for her heart.She did not use thermacare previously.She previously used other heat products (a moist heating pad) for pain relief.Consumer used the thermacare product maybe 3 hours and received 3rd degree burns on (b)(6) 2017.She did not feel like it was burning while she had the wrap on, but when she removed it, her back was red and pink and small portion of her skin was removed on (b)(6) 2017.She was still experiencing discomfort in (b)(6) 2017 and it was hard to put clothes up against it.She had a bandage on it with some neosporin.She saw an internal medicine doctor (b)(6) 2017 who told her it looked like shingles and that the thermacare aggravated the blisters.The doctor gave her pain pills and something for shingles (the prescription was for 1g use 3 times a day), but she was not going to take the product.She has had shingles before and kept up with her vaccines.She did not think it looked like shingles.There appeared to be some drainage in (b)(6) 2017, but the burn area was still pink and the skin was off.She had a picture to send in.She stated that the doctor put a light with heat (like a lamp) to her back to examine it.There were no other investigations.She was currently under the care of pain management and cardiologist for atrial fibrillation.She classified her skin tone as medium.She did not have sensitive skin.She did not have abnormal skin conditions.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of third degree burns was not resolved.The outcome of other events was unknown.According to product quality complaints, reasonably suggest device malfunction was no.Severity of harm was not applicable.Site sample status was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.Lot trend assessment and rationale was as a lot trend was not performed as the lot number is unknown.Conclusion was as follows 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, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up (12may2017): new information received from a contactable physician included the patient did not provide any information regarding the reported events with the use of the product.This follow-up is being submitted to notify that an investigation of the device cannot be conducted.Follow-up attempts have been completed and no further information is expected.Follow-up (27may2020): new information received from product quality complaints group includes investigation results.No follow-up attempts are possible.No further information is expected.
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Search Alerts/Recalls
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