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| Device Problems
Insufficient Heating (1287); Use of Device Problem (1670); Material Protrusion/Extrusion (2979)
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| Patient Problem
Partial thickness (Second Degree) Burn (2694)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term].I got a second degree burn on my side [burns second degree], when i went to take it off one of the magnets had apparently gotten hit [device issue], last time i used it kind of higher than normal because i had pulled muscles around my ribs [device use error], narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date at unknown dose for pulled muscles around ribs.The patient medical history and concomitant medications were not reported.The patient reported that "i have used this product for years and love it usually.However, this last time i used it kind of higher than normal because i had pulled muscles around my ribs.I put in on in the morning and went to work.About an hour into work i didn't think it was getting warm like usual but decided to leave it on longer.After about 4 1/2-5 hours when i went to take it off one of the magnets had apparently gotten hit and i got a second degree burn on my side.I have pictures but don't see anywhere for attachments.I want to bring this to your attention so it doesn't happen to someone else.It has been about a week now and i am still having problems getting it to heal so i had to go to a doctor.Please make consumers aware that even though they may not feel the heat there is still the risk of getting severely burned." the action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events "i got a second degree burn on my side" and "when i went to take it off one of the magnets had apparently gotten hit" was not resolved.The outcome of the event "last time i used it kind of higher than normal because i had pulled muscles around my ribs" was unknown.Additional information has been requested and will be provided as it becomes available.
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Manufacturer Narrative
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An investigation 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 and no batch number or return sample available for evaluation.A manufacturing and technical assessment not completed 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/ serious/unknown defect.The manufacturing operations employ quality control procedures, which include in- process testing and visual inspection, to ensure product quality.Without a return sample, the site cannot confirm the complaint.Lot trend assmt.& rationale: no lot trending performed on unknown lot numbers.Site had not received sample.Severity of harm was provided as s3.
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Event Description
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Event verbatim [preferred term], did not check the skin under the product while wearing thermacare/the patient read the usage instructions on thermacare before she used the product.[intentional device misuse], i got a second degree burn on my side/ burn/blister/sore [burns second degree], burn appeared to be getting infected/ the area around it was very inflamed [burn infection], pulled skin off [skin exfoliation], when i went to take it off one of the magnets had apparently gotten hit [device issue], last time i used it kind of higher than normal because i had pulled muscles around my ribs [device use issue], narrative: this is a spontaneous report from a contactable consumer (patient).A 53-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date at unknown dose for pulled muscles around ribs and sore muscles.The patient was not pregnant and was post-menopausal.Medical history included ongoing high blood pressure (bp), ankle injury, post-traumatic stress disorder (ptsd).The patient skin tone was very light or fair.She did not have sensitive skin and did not have any abnormal skin conditions.Concomitant medication included losartan (strength: 50 mg) for high bp, gabapentin (strength: 700 mg) for ankle injury, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (adderall) (strength: 20 mg, 10 mg) for ptsd, escitalopram oxalate (lexapro, strength: 30 mg) for ptsd.The patient previously took thermacare heatwraps and did not experience same problem/ symptom during previous use.The patient previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experienced a problem/symptom with one of these products.The patient reported that she had used this product for years and love it usually.However, this last time she used it kind of higher than normal because she had pulled muscles around her ribs.She put in on in the morning and went to work.About an hour into work she didn't think it was getting warm like usual but decided to leave it on longer.After about 4-5 (previously reported as 4 1/2-5) hours when she went to take it off one of the magnets had apparently gotten hit and i got a second degree burn on my side.She had pictures but didn't see anywhere for attachments.It had been about a week now and she was still having problems getting it to heal so she had to go to a doctor.The patient stated that please make consumers aware that even though they may not feel the heat there was still the risk of getting severely burned.The patient further reported that burn appeared to be getting infected and the area around it was very inflamed and sore so she went to an (clinic name) for treatment.The patient did not engage in exercise while using the product.The patient did not check the skin under the product while wearing thermacare.The patient read the usage instructions on thermacare before she used the product.The patient put wrap on adjusted so magnets were more to the side.Wore while at work.Never felt it get warm like it usually would.Took it off and a blister had already formed.The wrap had stuck to the blister and pulled skin off.There was no admission to hospital involved.Therapeutic measures were taken as a result of event i got a second degree burn on my side/ burn/blister/sore, burn appeared to be getting infected/ the area around it was very inflamed, pulled skin off included antibiotic and a prescription cream.The action taken in response to the events for thermacare heatwrap was permanently withdrawn.The outcome of the events "did not check the skin under the product while wearing thermacare/the patient read the usage instructions on thermacare before she used the product" and "last time i used it kind of higher than normal because i had pulled muscles around my ribs" was unknown, of the other events was not recovered.According to product complaint group: an investigation 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 and no batch number or return sample available for evaluation.A manufacturing and technical assessment not completed 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/ serious/unknown defect.The manufacturing operations employ quality control procedures, which include in- process testing and visual inspection, to ensure product quality.Without a return sample, the site cannot confirm the complaint.Lot trend assmt.& rationale: no lot trending performed on unknown lot numbers.Site had not received sample.Severity of harm was provided as s3.Follow up (25aug2020): new information received from a contactable consumer included: patient information (including patient age and gender), medical history, past drug information, action taken of the suspect product, concomitant medications, and event details (including no hospitalization, treatment information, additional event information burn/blister/sore for event burns second degree, and new events did not check the skin under the product while wearing thermacare, burn appeared to be getting infected/the area around it was very inflamed, pulled skin off).Follow-up (26aug2020): new information received from product complaint group includes investigation results.Follow-up (04sep2020): follow-up attempts completed.No further information expected.Follow-up (18sep2020): new information received from a product quality complaint group included: severity of harm rating assessment.Follow-up attempts are completed.No further information is expected.
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Event Description
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Event verbatim [preferred term].Did not check the skin under the product while wearing thermacare [intentional device misuse], i got a second degree burn on my side/ burn/blister/sore [burns second degree], burn appeared to be getting infected/ the area around it was very inflamed [burn infection], pulled skin off [skin exfoliation], when i went to take it off one of the magnets had apparently gotten hit [device issue], last time i used it kind of higher than normal because i had pulled muscles around my ribs [device use error].Narrative: this is a spontaneous report from a contactable consumer (patient).A 53-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date at unknown dose for pulled muscles around ribs and sore muscles.The patient was not pregnant and was post-menopausal.Medical history included high blood pressure (bp), ankle injury, post-traumatic stress disorder (ptsd).The patient skin tone was very light or fair.She did not have sensitive skin and did not have any abnormal skin conditions.Concomitant medication included losartan for high bp, gabapentin for ankle injury, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (adderall) (strength: 20 mg, 10 mg) for ptsd (post-traumatic stress disorder), escitalopram oxalate (lexapro) for ptsd (post-traumatic stress disorder).The patient previously took thermacare heatwraps and did not experienced same problem/ symptom during previous use.The patient previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experienced a problem/symptom with one of these products.The patient reported that she had used this product for years and love it usually.However, this last time she used it kind of higher than normal because she had pulled muscles around her ribs.She put in on in the morning and went to work.About an hour into work she didn't think it was getting warm like usual but decided to leave it on longer.After about 4-5 (previously reported as 4 1/2-5) hours when she went to take it off one of the magnets had apparently gotten hit and i got a second degree burn on my side.She had pictures but didn't see anywhere for attachments.It had been about a week now and she was still having problems getting it to heal so she had to go to a doctor.The patient stated that please make consumers aware that even though they may not feel the heat there was still the risk of getting severely burned.The patient further reported that burn appeared to be getting infected and the area around it was very inflamed and sore so she went to an (clinic name) for treatment.The patient did not engage in exercise while using the product.The patient did not check the skin under the product while wearing thermacare.The patient read the usage instructions on thermacare before she used the product.The patient put wrap on adjusted so magnets were more to the side.Wore while at work.Never felt it get warm like it usually would.Took it off and a blister had already formed.The wrap had stuck to the blister and pulled skin off.There was no admission to hospital involved.Therapeutic measures were taken as a result of event i got a second degree burn on my side/ burn/blister/sore, burn appeared to be getting infected/ the area around it was very inflamed, pulled skin off included antibiotic and a prescription cream.The action taken in response to the events for thermacare heatwrap was permanently withdrawn.The outcome of the events "did not check the skin under the product while wearing thermacare" was unknown, of the other events was not recovered.Additional information has been requested and will be provided as it becomes available.Follow up (25aug2019): new information received from a contactable consumer included: patient information (including patient age and gender), medical history, past drug information, action taken of the suspect product, concomitant medications, and event details (including no hospitalization, treatment information, additional event information burn/blister/sore for event burns second degree, and new events did not check the skin under the product while wearing thermacare, burn appeared to be getting infected/the area around it was very inflamed, pulled skin off).
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Manufacturer Narrative
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An investigation 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 and no batch number or return sample available for evaluation.A manufacturing and technical assessment not completed 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/ serious/unknown defect.The manufacturing operations employ quality control procedures, which include in- process testing and visual inspection, to ensure product quality.Without a return sample, the site cannot confirm the complaint.Lot trend assmt.& rationale: no lot trending performed on unknown lot numbers.Site had not received sample.
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Event Description
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Event verbatim [preferred term]: did not check the skin under the product while wearing thermacare [intentional device misuse], i got a second degree burn on my side/ burn/blister/sore [burns second degree], burn appeared to be getting infected/ the area around it was very inflamed [burn infection], pulled skin off [skin exfoliation], when i went to take it off one of the magnets had apparently gotten hit [device issue], last time i used it kind of higher than normal because i had pulled muscles around my ribs [device use error], , narrative: this is a spontaneous report from a contactable consumer (patient).A 53-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date at unknown dose for pulled muscles around ribs and sore muscles.The patient was not pregnant and was post-menopausal.Medical history included high blood pressure (bp), ankle injury, post-traumatic stress disorder (ptsd).The patient skin tone was very light or fair.She did not have sensitive skin and did not have any abnormal skin conditions.Concomitant medication included losartan (strength: 50 mg) for high bp, gabapentin (strength: 700 mg) for ankle injury, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (adderall) (strength: 20 mg, 10 mg) for ptsd, escitalopram oxalate (lexapro, strength: 30 mg) for ptsd.The patient previously took thermacare heatwraps and did not experienced same problem/ symptom during previous use.The patient previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experienced a problem/symptom with one of these products.The patient reported that she had used this product for years and love it usually.However, this last time she used it kind of higher than normal because she had pulled muscles around her ribs.She put in on in the morning and went to work.About an hour into work she didn't think it was getting warm like usual but decided to leave it on longer.After about 4-5 (previously reported as 4 1/2-5) hours when she went to take it off one of the magnets had apparently gotten hit and i got a second degree burn on my side.She had pictures but didn't see anywhere for attachments.It had been about a week now and she was still having problems getting it to heal so she had to go to a doctor.The patient stated that please make consumers aware that even though they may not feel the heat there was still the risk of getting severely burned.The patient further reported that burn appeared to be getting infected and the area around it was very inflamed and sore so she went to an (clinic name) for treatment.The patient did not engage in exercise while using the product.The patient did not check the skin under the product while wearing thermacare.The patient read the usage instructions on thermacare before she used the product.The patient put wrap on adjusted so magnets were more to the side.Wore while at work.Never felt it get warm like it usually would.Took it off and a blister had already formed.The wrap had stuck to the blister and pulled skin off.There was no admission to hospital involved.Therapeutic measures were taken as a result of event i got a second degree burn on my side/ burn/blister/sore, burn appeared to be getting infected/ the area around it was very inflamed, pulled skin off included antibiotic and a prescription cream.The action taken in response to the events for thermacare heatwrap was permanently withdrawn.The outcome of the events "did not check the skin under the product while wearing thermacare, last time i used it kind of higher than normal because i had pulled muscles around my ribs" was unknown, of the other events was not recovered.According to product complaint group: an investigation 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 and no batch number or return sample available for evaluation.A manufacturing and technical assessment not completed 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/ serious/unknown defect.The manufacturing operations employ quality control procedures, which include in- process testing and visual inspection, to ensure product quality.Without a return sample, the site cannot confirm the complaint.Lot trend assmt.& rationale: no lot trending performed on unknown lot numbers.Site had not received sample.Follow up (25aug2019): new information received from a contactable consumer included: patient information (including patient age and gender), medical history, past drug information, action taken of the suspect product, concomitant medications, and event details (including no hospitalization, treatment information, additional event information burn/blister/sore for event burns second degree, and new events did not check the skin under the product while wearing thermacare, burn appeared to be getting infected/the area around it was very inflamed, pulled skin off).Follow-up (26aug2020): new information received from product complaint group includes investigation results.
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Search Alerts/Recalls
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