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| Device Problem
Use of Device Problem (1670)
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| Patient Problems
Abrasion (1689); Erythema (1840); Scarring (2061); Burn, Thermal (2530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 10/01/2020 |
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Event Type
Injury
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Event Description
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Not check skin under product while wearing/ read instructions before use/attached adhesive to body/wearing a snug waistband/belt or similar or otherwise applied pressure over the area [intentional device misuse], used 8-9 hours [intentional device use issue], burn/is still reddish/areas are red [thermal burn], one is oozing [skin weeping], 5 burn marks [scar], when removing wrap it took off her skin with it [skin exfoliation].Narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6)-year-old female (non- pregnant) patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from (b)(6) 2020 for 8-9 hours for low back pain, and ongoing unspecified steroid injections from an unspecified date administered in lower back as needed for low back pain received at pain management office.Medical history included ongoing low back problems.The patient was currently under the care of a physician for low back problems.The patient did not have conditions like diabetes, poor circulation, heart disease, difficulty feeling heat or pain on skin, rheumatoid arthritis, decreased sensation or neuropathy.The patient classified her skin tone as medium.The patient did not have sensitive skin or any abnormal skin conditions.Concomitant medications included regular over the counter vitamins daily, but unable to provide any further details.The patient previously used thermacare heatwrap for 8-9 hours per day in (b)(6) 2020, and had no problem with it and threw that away.The patient previously used moist heating pad (electric) in (b)(6) 2020, and unable to provide exact time frame, put on at bedtime and it automatically shut off and did not previously experienced a problem with the product.The patient reported she had burns from wearing the theramacare wraps for the back in (b)(6) 2020.The patient was wearing several layers of clothing over the thermacare product.She was wearing a snug waistband/belt or similar or otherwise applied pressure over the area (for example, prolonged car ride).She attached the adhesive to body.She put product on in the morning and took it off in the evening under her regular clothing.She did all normal daily activity, nothing new.She did not engage in exercise while using the product (for example, running, bicycling); did not check her skin under the product while wearing thermacare; she did read the usage instructions on thermacare before she used the product.The patient had it on about 8-9 hours.When removing wrap it took off her skin with it.She had 5 burns on lower back and one of them was oozing, areas reddish.She had 5 burn marks/areas and one was oozing and they were burn marks.They were not scabbed yet.The patient did not consult a healthcare professional for the symptoms, but was at her pain management appointment, she had back injections on (b)(6) 2020 and the provider there saw the areas, asked what had happened.She had the pain management doctor/nurse take pictures on her phone.She asked if there was anything he could prescribed.Pain management doctor recommended for her to put on neosporin to the areas.This just happened last week (in (b)(6) 2020) and it hadn't improved and was still reddish.The patient still had burns and oozing of one area and redness.The color of the box she purchased was red box.She ordered 2 boxes at the same time.There were 2 in each box/pack.She used this one last week (in (b)(6) 2020) and threw it away after use.She still had one unopened box left.Packaging was sealed and intact.The action taken in response to adverse event was unknown.Seriousness criteria was reported as damage of body structure.The patient used recommended neosporin to areas as treatment.The outcome of event "used 8-9 hours" "not check skin under the product while wearing/ did read the usage instructions before use/attached the adhesive to body/wearing a snug waistband/belt or similar or otherwise applied pressure over the area" was unknown.The outcome of the remaining events was not recovered.The patient considered there was a reasonable possibility that "had 5 burn marks after use and one area that is still oozing/areas are red" was related to the device.Additional information has been requested and will be provided as it becomes available.
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Event Description
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Event verbatim [preferred term] not check skin under product while wearing/ read instructions before use/attached adhesive to body/wearing a snug waistband/belt or similar or otherwise applied pressure over the area [intentional device misuse], used 8-9 hours [intentional device use issue], burn/is still reddish/areas are red [thermal burn], one is oozing [skin weeping], 5 burn marks [scar], when removing wrap it took off her skin with it [skin exfoliation], , narrative: this is a spontaneous report from a contactable consumer (patient) and other consumer.A 65-year-old female (non- pregnant) patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from (b)(6) 2020 to (b)(6) 2020 for 8-9 hours for low back pain, and ongoing unspecified steroid injections from an unspecified date administered in lower back as needed for low back pain received at pain management office.Medical history included ongoing low back problems.The patient was currently under the care of a physician for low back problems.The patient did not have conditions like diabetes, poor circulation, heart disease, difficulty feeling heat or pain on skin, rheumatoid arthritis, decreased sensation or neuropathy.The patient classified her skin tone as medium.The patient did not have sensitive skin or any abnormal skin conditions.Concomitant medications included regular over the counter vitamins daily, but unable to provide any further details.The patient previously used thermacare heatwrap for 8-9 hours per day in (b)(6) 2020, and had no problem with it and threw that away.The patient previously used moist heating pad (electric) in (b)(6) 2020, and unable to provide exact time frame, put on at bedtime and it automatically shut off and did not previously experienced a problem with the product.The patient reported she had burns from wearing the theramacare wraps for the back in (b)(6) 2020.The patient was wearing several layers of clothing over the thermacare product.She was wearing a snug waistband/belt or similar or otherwise applied pressure over the area (for example, prolonged car ride).She attached the adhesive to body.She put product on in the morning and took it off in the evening under her regular clothing.She did all normal daily activity, nothing new.She did not engage in exercise while using the product (for example, running, bicycling); did not check her skin under the product while wearing thermacare; she did read the usage instructions on thermacare before she used the product.The patient had it on about 8-9 hours.When removing wrap it took off her skin with it.She had 5 burns on lower back and one of them was oozing, areas reddish.She had 5 burn marks/areas and one was oozing and they were burn marks.They were not scabbed yet.The patient did not consult a healthcare professional for the symptoms, but was at her pain management appointment, she had back injections on (b)(6) 2020 and the provider there saw the areas, asked what had happened.She had the pain management doctor/nurse take pictures on her phone.She asked if there was anything he could prescribed.Pain management doctor recommended for her to put on neosporin to the areas.This just happened last week (in (b)(6) 2020) and it hadn't improved and was still reddish.The patient still had burns and oozing of one area and redness.The color of the box she purchased was red box.She ordered 2 boxes at the same time.There were 2 in each box/pack.She used this one last week (in (b)(6) 2020) and threw it away after use.She still had one unopened box left.Packaging was sealed and intact.The action taken in response to adverse event was unknown.Seriousness criteria was reported as damage of body structure.The patient used recommended neosporin to areas as treatment.The outcome of event "used 8-9 hours" "not check skin under the product while wearing/ did read the usage instructions before use/attached the adhesive to body/wearing a snug waistband/belt or similar or otherwise applied pressure over the area" was unknown.The outcome of the remaining events was not recovered.The patient considered there was a reasonable possibility that "had 5 burn marks after use and one area that is still oozing/areas are red" was related to the device.Additional information has been requested and will be provided as it becomes available.Follow-up (04nov2020): new information received from a contactable consumer includes new reporter information.
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Event Description
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Event [preferred term] not check skin under product while wearing/ read instructions before use/attached adhesive to body/wearing a snug waistband/belt or similar or otherwise applied pressure over the area [intentional device misuse], used 8-9 hours [intentional device use issue], burn/is still reddish/areas are red [thermal burn], one is oozing [skin weeping], 5 burn marks [scar], when removing wrap, it took off her skin with it [skin exfoliation], narrative: this is a spontaneous report from a contactable consumer (patient) and other consumer.A 65-year-old female (non- pregnant) patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from (b)(6) 2020 to (b)(6) 2020 for 8-9 hours for low back pain, and ongoing unspecified steroid injections from an unspecified date administered in lower back as needed for low back pain received at pain management office.Medical history included ongoing low back problems.The patient was currently under the care of a physician for low back problems.The patient did not have conditions like diabetes, poor circulation, heart disease, difficulty feeling heat or pain on skin, rheumatoid arthritis, decreased sensation or neuropathy.The patient classified her skin tone as medium.The patient did not have sensitive skin or any abnormal skin conditions.Concomitant medications included regular over the counter vitamins daily, but unable to provide any further details.The patient previously used thermacare heatwrap for 8-9 hours per day in (b)(6) 2020 and had no problem with it and threw that away.The patient previously used moist heating pad (electric) in (b)(6) 2020, and unable to provide exact time frame, put on at bedtime and it automatically shut off and did not previously experienced a problem with the product.The patient reported she had burns from wearing the theramacare wraps for the back in (b)(6) 2020.The patient was wearing several layers of clothing over the thermacare product.She was wearing a snug waistband/belt or similar or otherwise applied pressure over the area (for example, prolonged car ride).She attached the adhesive to body.She put product on in the morning and took it off in the evening under her regular clothing.She did all normal daily activity, nothing new.She did not engage in exercise while using the product (for example, running, bicycling); did not check her skin under the product while wearing thermacare; she did read the usage instructions on thermacare before she used the product.The patient had it on about 8-9 hours.When removing wrap, it took off her skin with it.She had 5 burns on lower back and one of them was oozing, areas reddish.She had 5 burn marks/areas and one was oozing and they were burn marks.They were not scabbed yet.The patient did not consult a healthcare professional for the symptoms, but was at her pain management appointment, she had back injections on (b)(6) 2020 and the provider there saw the areas, asked what had happened.She had the pain management doctor/nurse take pictures on her phone.She asked if there was anything he could prescribed.Pain management doctor recommended for her to put on neosporin to the areas.This just happened last week (in (b)(6) 2020) and it hadn't improved and was still reddish.The patient still had burns and oozing of one area and redness.The color of the box she purchased was red box.She ordered 2 boxes at the same time.There were 2 in each box/pack.She used this one last week (in (b)(6) 2020) and threw it away after use.She still had one unopened box left.Packaging was sealed and intact.The action taken in response to adverse event was unknown.Seriousness criteria was reported as damage of body structure.The patient used recommended neosporin to areas as treatment.The outcome of event "used 8-9 hours" "not check skin under the product while wearing/ did read the usage instructions before use/attached the adhesive to body/wearing a snug waistband/belt or similar or otherwise applied pressure over the area" was unknown.The outcome of the remaining events was not recovered.The patient considered there was a reasonable possibility that "had 5 burn marks after use and one area that is still oozing/areas are red" was related to the device.According to product quality complaint group: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: 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 or a 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 adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Lot trend assmt.& rationale: a lot of trends was not performed as the lot number is unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment lbh adverse event/serious/unknown (b)(6) 2017 to (b)(6) 2020.No further action required.Process related was no.Final confirmation status was not confirmed.Site sample status was not received.Follow-up (04nov2020): new information received from a contactable consumer includes new reporter information.Follow-up (04nov2020): new information received from a product quality complaint group includes investigation results.
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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.Conclusion: 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 or a 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 adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Lot trend assmt.& rationale: a lot of trends was not performed as the lot number is unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.No further action required.Process related was no.Final confirmation status was not confirmed.Site sample status was not received.
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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.Conclusion: 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 or a 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 adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.No further action required.Process related was no.Final confirmation status was not confirmed.Site sample status was not received.
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Event Description
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Event verbatim [preferred term] not check skin under product while wearing/ read instructions before use/attached adhesive to body/wearing a snug waistband/belt or similar or otherwise applied pressure over the area [intentional device misuse], used 8-9 hours [intentional device use issue], burn/is still reddish/areas are red [thermal burn], one is oozing [skin weeping], 5 burn marks [scar], when removing wrap it took off her skin with it [skin exfoliation], , narrative: this is a spontaneous report from a contactable consumer (patient) and other consumer.A 65-year-old female (non- pregnant) patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from (b)(6) 2020 to (b)(6) 2020 for 8-9 hours for low back pain, and ongoing unspecified steroid injections from an unspecified date administered in lower back as needed for low back pain received at pain management office.Medical history included ongoing low back problems.The patient was currently under the care of a physician for low back problems.The patient did not have conditions like diabetes, poor circulation, heart disease, difficulty feeling heat or pain on skin, rheumatoid arthritis, decreased sensation or neuropathy.The patient classified her skin tone as medium.The patient did not have sensitive skin or any abnormal skin conditions.Concomitant medications included regular over the counter vitamins daily, but unable to provide any further details.The patient previously used thermacare heatwrap for 8-9 hours per day in (b)(6) 2020 and had no problem with it and threw that away.The patient previously used moist heating pad (electric) in (b)(6) 2020, and unable to provide exact time frame, put on at bedtime and it automatically shut off and did not previously experienced a problem with the product.The patient reported she had burns from wearing the theramacare wraps for the back in (b)(6) 2020.The patient was wearing several layers of clothing over the thermacare product.She was wearing a snug waistband/belt or similar or otherwise applied pressure over the area (for example, prolonged car ride).She attached the adhesive to body.She put product on in the morning and took it off in the evening under her regular clothing.She did all normal daily activity, nothing new.She did not engage in exercise while using the product (for example, running, bicycling); did not check her skin under the product while wearing thermacare; she did read the usage instructions on thermacare before she used the product.The patient had it on about 8-9 hours.When removing wrap it took off her skin with it.She had 5 burns on lower back and one of them was oozing, areas reddish.She had 5 burn marks/areas and one was oozing and they were burn marks.They were not scabbed yet.The patient did not consult a healthcare professional for the symptoms, but was at her pain management appointment, she had back injections on (b)(6) 2020 and the provider there saw the areas, asked what had happened.She had the pain management doctor/nurse take pictures on her phone.She asked if there was anything he could prescribed.Pain management doctor recommended for her to put on neosporin to the areas.This just happened last week (in (b)(6) 2020) and it hadn't improved and was still reddish.The patient still had burns and oozing of one area and redness.The color of the box she purchased was red box.She ordered 2 boxes at the same time.There were 2 in each box/pack.She used this one last week (in (b)(6) 2020) and threw it away after use.She still had one unopened box left.Packaging was sealed and intact.A sample of the product was available to be returned.The action taken in response to adverse event was unknown.Seriousness criteria was reported as damage of body structure.The patient used recommended neosporin to areas as treatment.The outcome of event "used 8-9 hours" "not check skin under the product while wearing/ did read the usage instructions before use/attached the adhesive to body/wearing a snug waistband/belt or similar or otherwise applied pressure over the area" was unknown.The outcome of the remaining events was not recovered.The patient considered there was a reasonable possibility that "had 5 burn marks after use and one area that is still oozing/areas are red" was related to the device.According to product quality complaint group: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: 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 or a 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 adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment lbh adverse event/serious/unknown 26oct2017 to 26oct2020.No further action required.Process related was no.Final confirmation status was not confirmed.Site sample status was not received.According to product quality complaint group on 26feb2021: reasonably suggest device malfunction: yes, severity of harm: s3.Follow-up (04nov2020): new information received from a contactable consumer includes new reporter information.Follow-up (04nov2020): new information received from a product quality complaint group includes investigation results.Follow-up (10nov2020): follow-up attempts completed.No further information expected.Follow-up (26feb2021): new information received from a product quality complaint group includes: : manufacturing site severity and malfunction assessment provided.Follow-up attempts are completed.No further information is expected.
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Search Alerts/Recalls
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