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| Lot Number W81909 |
| Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Itching Sensation (1943); Tingling (2171); Burn, Thermal (2530)
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| Event Date 05/01/2019 |
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Event Type
Injury
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Event Description
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Applied thermacare on back and spot got very warm and started to itch [pruritus], hot and itching/very warm spot [feeling hot], the spot on her back was hot and itching and tingling [paraesthesia], she thought the spot on her back was due to her movement with the material of the wrap with the cells in it [device issue], burned like hell [thermal burn], skin rubbed off [skin exfoliation], she put on the wrap all day and at night when she took off the thermacare wrap at night [device use error].Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6) female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number: w81909, expiration date jul2021, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for back pain.Medical history included war injury, aches and pains from being in the military, bad knees and she shrunk a little.Concomitant medications were none.Consumer purchased the heatwraps from (site) on (b)(6) 2019 and got the email from (site) telling her about the recall and she had already used the product and asking what to do now.She did notice where she put the thermacare heatwrap on her back that it activated a spot on her back.She had back pain from four years ago and used the wraps all the time.She pulled a muscle in her hip many years ago when she was in the military.When she bought these thermacare heatwraps she put the wraps on her back where she normally placed them and got a very warm spot that started to itch on her back.She thought the spot on her back was due to her movement with the material of the wrap with the cells in it.She stated the thermacare wrap heated and she threw it away and then put another one on a couple of days later and the same spot on her back started itching again.She did not go to the hcp because it was not a thing and she did not notice her skin falling off or hair falling off or a burnt spot; she did not notice these things.The spot on her back was hot and itching and tingling for awhile and first it tingled and later on when it cooled off it started itching and she thought maybe her clothes had irritated the same spot.She was out doing yardwork on (b)(6) this year and noted the spot on her back somewhere around that time and it had now completely resolved.The spot was little and only lasted a couple of times because she put on the wrap all day and at night when she took off the thermacare wrap at night she took a shower and noted it burned like hell and she thought her skin rubbed off.She stated in her shower when the hot water hit the spot it burned but she did not realize it may be related to the heatwrap because she had never had an issue before.She was asked if she had treatment for the adverse event and stated she did and because she was feeling so itchy she put on antibiotic cream and benadryl on it and stated none of that helped the itchiness.She clarified she did not take benadryl but instead only used cortisone 10.She took everything out of the box because the box was bulky and applied the heatwrap on monday and she did not have any more.She stated this showed how bad her back was and she had always used the thermacare heatwraps and used them when she was in the military many years ago.She had another (brand name) heatwrap and the (brand name) brand and the thermacare brands were the only ones that help her back pain which was an old war injury.She was asked for any other heatwraps that did not help her back pain and she stated the (brand name) and thermacare brands were the only two she had used and she was in the army for 22 years and hurt sometimes from her old wounds.She had used (brand name) muscle patches and tiger balm patches and a cheaper version of an absorbing patch but stated they were all just ok in terms of her back pain and she had no lot numbers, upc numbers or expiry dates to provide as all of those patches had been discarded.She got these thermacare heatwraps on (b)(6) 2019 and there were two boxes and each box had two wraps in each box.She had no other lot numbers, expiry dates or upc/udi numbers to provide and she only had the one wrap left that she applied.The action taken in response to the events of the product was unknown.The outcome of applied thermacare on back and spot got very warm and started to itch, the spot on her back was hot and itching and tingling, she thought the spot on her back was due to her movement with the material of the wrap with the cells in it was 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 events of pruritus, feeling hot, paraesthesia, thermal burn, skin exfoliation, device use error and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] burned like hell/the spot on her back was hot and itching and tingling [thermal burn] , she was sleeping while wearing the product before the burning occurred/she attached the adhesive to body and clothing/she read directions [intentional device misuse] , skin rubbed off [skin exfoliation] ,.Case narrative:this is a spontaneous report from a contactable consumer.This 67-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number: w81909, expiration date jul2021, via an unspecified route of administration from 01may2019 to 15may2019 at unknown dose for back pain and hip pain.She was not pregnant.Medical history included back and hip discomfort, war injury, aches and pains from being in the military, bad knees and she shrunk a little.Concomitant medication included camphor, eucalyptus globulus oil, menthol, syzygium aromaticum oil (tiger balm) for back and hip discomfort (after rinsing the area she waited until the next day and used tiger balm rub 1 dose daily).She also used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) from 01-15may2019.She previously used thermacare over the years and did not experience below problem.She had had back pain from four years before and used the wraps all the time.She pulled a muscle in her hip many years before when she was in the military.Consumer purchased the heatwraps on 09may2019 and got the email telling her about the recall and she had already used the product and asked what to do now.She did notice where she put the thermacare heatwrap on her back that it activated a spot on her back.When she bought these thermacare heatwraps she put the wraps on her back where she normally placed them and got a very very warm spot that started to itch on her back.She thought the spot on her back was due to her movement with the material of the wrap with the cells in it.When asked whether it referred a product complaint that something wrong with the product caused events, she clarified she noticed a burning feeling on her back (right side) in may2019 (reported as 01-15may2019).She took the heatwrap off.Later in the day the burning turned to stinging.Later in the night into the next day she had an itching feeling in may2019 where the burning and tingling was.She stated the thermacare wrap heated and she threw it away and then put another one on a couple of days later and the same spot on her back started itching again.She did not go to the hcp because it was not a thing and she did not notice her skin falling off or hair falling off or a burnt spot; she did not notice these things.The spot on her back was hot and itching and tingling for a while and first it tingled and later on when it cooled off it started itching and she thought maybe her clothes had irritated the same spot.She was out doing yardwork on the friday before mother's day this year and noted the spot on her back somewhere around that time and it had now completely resolved.The spot was little and only lasted a couple of times because she put on the wrap all day (she clarified that she used it up to the 8 hr.)and at night when she took off the thermacare wrap at night she took a shower and noted it burned like hell and she thought her skin rubbed off (in may2019).She stated in her shower when the hot water hit the spot it burned but she did not realize it may be related to the heatwrap because she had never had an issue before.She was asked if she had treatment for the adverse event and stated she did and because she was feeling so itchy she put on antibiotic cream and benadryl on it and stated none of that helped the itchiness.She clarified she did not take benadryl but instead only used cortisone 10.She took everything out of the box because the box was bulky and applied the heatwrap on monday.She stated this showed how bad her back was and she had always used the thermacare heatwraps and used them when she was in the military many years before.She was not hospitalized due to events hot and itching and tingling.She had another (brand name) heatwrap and the (brand name) brand and the thermacare brands were the only ones that help her back pain which was an old war injury.She was asked for any other heatwraps that did not help her back pain and she stated the (brand name) and thermacare brands were the only two she had used and she was in the army for 22 years and hurt sometimes from her old wounds.She had used (brand name) muscle patches and tiger balm patches and a cheaper version of an absorbing patch but stated they were all just ok in terms of her back pain.She got these thermacare heatwraps on 24apr2019 and there were two boxes and each box had two wraps in each box.She had no other lot numbers, expiry dates or upc/udi numbers to provide and she only had the one wrap left that she applied.She classified her skin tone as dark or olive.She denied sensitive skin or any abnormal skin conditions.The color of the box she purchased was red.There were some products remaining.She was sleeping while wearing the product before the burning occurred.She attached the adhesive to body and clothing.She read directions.She engaged house work while using the product.She checked her skin under the product while wearing thermacare when she felt the burning on her hip and back.The action taken in response to the events of the product was stopped on 15may2019.The outcome of burn, hot and itching, tingling was resolved in 2019.The outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: the events "spot got very very warm and started to itch, hot and itching/very warm spot, the spot on her back was hot and itching and tingling, skin rubbed off" were downgraded to non-serious, the events "she thought the spot on her back was due to her movement with the material of the wrap with the cells in it, she put on the wrap all day and at night when she took off the thermacare wrap at night" were deleted.Follow-up (14jun2019): new information received from the same contactable consumer includes: additional medical history, product data (therapy dates, additional indication), concomitant medication, and event data (updated onset date and new event she was sleeping while wearing the product before the burning occurred/she attached the adhesive to body and clothing/she read directions, subsuming pruritus, feeling hot and paresthesia under burn).Company clinical evaluation comment: based on the information provided, the events thermal burns and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event skin exfoliation is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events thermal burns and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event skin exfoliation is non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] burned like hell [thermal burn] , applied thermacare on back and spot got very very warm and started to itch [pruritus] , hot and itching/very warm spot [feeling hot] , the spot on her back was hot and itching and tingling [paraesthesia] , skin rubbed off [skin exfoliation] ,.Case narrative:this is a spontaneous report from a contactable consumer.This 67-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number: w81909, expiration date jul2021, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for back pain.Medical history included war injury, aches and pains from being in the military, bad knees and she shrunk a little.Concomitant medications were none.Consumer purchased the heatwraps from (site) on 09may2019 and got the email from (site) telling her about the recall and she had already used the product and asking what to do now.She did notice where she put the thermacare heatwrap on her back that it activated a spot on her back.She had had back pain from four years ago and used the wraps all the time.She pulled a muscle in her hip many years ago when she was in the military.When she bought these thermacare heatwraps she put the wraps on her back where she normally placed them and got a very very warm spot that started to itch on her back.She thought the spot on her back was due to her movement with the material of the wrap with the cells in it.She stated the thermacare wrap heated and she threw it away and then put another one on a couple of days later and the same spot on her back started itching again.She did not go to the hcp because it was not a thing and she did not notice her skin falling off or hair falling off or a burnt spot; she did not notice these things.The spot on her back was hot and itching and tingling for awhile and first it tingled and later on when it cooled off it started itching and she thought maybe her clothes had irritated the same spot.She was out doing yardwork on the friday before mother's day this year and noted the spot on her back somewhere around that time and it had now completely resolved.The spot was little and only lasted a couple of times because she put on the wrap all day and at night when she took off the thermacare wrap at night she took a shower and noted it burned like hell and she thought her skin rubbed off.She stated in her shower when the hot water hit the spot it burned but she did not realize it may be related to the heatwrap because she had never had an issue before.She was asked if she had treatment for the adverse event and stated she did and because she was feeling so itchy she put on antibiotic cream and benadryl on it and stated none of that helped the itchiness.She clarified she did not take benadryl but instead only used cortisone 10.She took everything out of the box because the box was bulky and applied the heatwrap on monday and she did not have any more.She stated this showed how bad her back was and she had always used the thermacare heatwraps and used them when she was in the military many years ago.She had another (brand name) heatwrap and the (brand name) brand and the thermacare brands were the only ones that help her back pain which was an old war injury.She was asked for any other heatwraps that did not help her back pain and she stated the (brand name) and thermacare brands were the only two she had used and she was in the army for 22 years and hurt sometimes from her old wounds.She had used (brand name) muscle patches and tiger balm patches and a cheaper version of an absorbing patch but stated they were all just ok in terms of her back pain and she had no lot numbers, upc numbers or expiry dates to provide as all of those patches had been discarded.She got these thermacare heatwraps on 24apr2019 and there were two boxes and each box had two wraps in each box.She had no other lot numbers, expiry dates or upc/udi numbers to provide and she only had the one wrap left that she applied.The action taken in response to the events of the product was unknown.The outcome of applied thermacare on back and spot got very very warm and started to itch, the spot on her back was hot and itching and tingling, she thought the spot on her back was due to her movement with the material of the wrap with the cells in it was resolved.The outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: the events "spot got very very warm and started to itch, hot and itching/very warm spot, the spot on her back was hot and itching and tingling, skin rubbed off" were downgraded to non-serious, the events "she thought the spot on her back was due to her movement with the material of the wrap with the cells in it, she put on the wrap all day and at night when she took off the thermacare wrap at night" were deleted.Company clinical evaluation comment: based on the information provided, the event thermal burn as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events pruritus, feeling hot, paraesthesia, and skin exfoliation are non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the event thermal burn as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events pruritus, feeling hot, paraesthesia, and skin exfoliation are non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] burned like hell/the spot on her back was hot and itching and tingling [thermal burn] , she was sleeping while wearing the product before the burning occurred/she attached the adhesive to body and clothing/she read directions [intentional device misuse] , skin rubbed off [skin exfoliation] ,.Case narrative:this is a spontaneous report from a contactable consumer.This 67-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number: w81909, expiration date jul2021, via an unspecified route of administration from 01may2019 to 15may2019 at unknown dose for back pain and hip pain.She was not pregnant.Medical history included rheumatoid arthritis, back and hip discomfort, war injury, aches and pains from being in the military, bad knees and she shrunk a little.The patient was post-menopausal.She was not currently under the care of a physician for any medical condition.Concomitant medication included camphor, eucalyptus globulus oil, menthol, syzygium aromaticum oil (tiger balm) for back and hip discomfort (after rinsing the area she waited until the next day and used tiger balm rub 1 dose daily).She also used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) from (b)(6) -(b)(6) 2019.She had not previously experienced a problem/ symptom with one of these products.She has previously used thermacare over the years and did not experience the same problem.She had had back pain from four years before and used the wraps all the time.She pulled a muscle in her hip many years before when she was in the military.Consumer purchased the heatwraps on (b)(6) 2019 and got the email telling her about the recall and she had already used the product and asked what to do now.She did notice where she put the thermacare heatwrap on her back that it activated a spot on her back.When she bought these thermacare heatwraps she put the wraps on her back where she normally placed them and got a very very warm spot that started to itch on her back.She thought the spot on her back was due to her movement with the material of the wrap with the cells in it.When asked whether it referred a product complaint that something wrong with the product caused events, she clarified she noticed a burning feeling on her back (right side) in (b)(6) 2019 (reported as (b)(6) -(b)(6) 2019).She took the heatwrap off.Later in the day the burning turned to stinging.Later in the night into the next day she had an itching feeling in (b)(6) 2019 where the burning and tingling was.She also reported the location of the burning, itching-tingling as on her "back hip (right)." she stated the thermacare wrap heated and she threw it away and then put another one on a couple of days later and the same spot on her back started itching again.She did not go to the hcp because it was not a thing and she did not notice her skin falling off or hair falling off or a burnt spot; she did not notice these things.The spot on her back was hot and itching and tingling for a while and first it tingled and later on when it cooled off it started itching and she thought maybe her clothes had irritated the same spot.She was out doing yardwork on the friday before mother's day this year and noted the spot on her back somewhere around that time and it had now completely resolved.The spot was little and only lasted a couple of times because she put on the wrap all day (she clarified that she used it up to the 8 hr) and at night when she took off the thermacare wrap at night she took a shower and noted it burned like hell and she thought her skin rubbed off (in (b)(6) 2019).She stated in her shower when the hot water hit the spot it burned but she did not realize it may be related to the heatwrap because she had never had an issue before.She was asked if she had treatment for the adverse event and stated she did and because she was feeling so itchy she put on antibiotic cream and benadryl on it and stated none of that helped the itchiness.She clarified she did not take benadryl but instead only used cortisone 10.She took everything out of the box because the box was bulky and applied the heatwrap on monday.She stated this showed how bad her back was and she had always used the thermacare heatwraps and used them when she was in the military many years before.She was not hospitalized due to events hot and itching and tingling.She had another (brand name) heatwrap and the (brand name) brand and the thermacare brands were the only ones that help her back pain which was an old war injury.She was asked for any other heatwraps that did not help her back pain and she stated the (brand name) and thermacare brands were the only two she had used and she was in the army for 22 years and hurt sometimes from her old wounds.She had used (brand name) muscle patches and tiger balm patches and a cheaper version of an absorbing patch but stated they were all just ok in terms of her back pain.She got these thermacare heatwraps on (b)(6) 2019 and there were two boxes and each box had two wraps in each box.She had no other lot numbers, expiry dates or upc/udi numbers to provide and she only had the one wrap left that she applied.She classified her skin tone as dark or olive.She denied sensitive skin or any abnormal skin conditions.The color of the box she purchased was red.There were some products remaining.She was sleeping while wearing the product before the burning occurred.She attached the adhesive to body and clothing.She read directions.She engaged in house work while using the product.She checked her skin under the product while wearing thermacare when she felt the burning on her hip and back.The action taken in response to the events of the product was stopped on (b)(6) 2019.The outcome of burn, hot and itching, tingling was resolved in 2019.The symptoms lasted for 2 days.The outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: the events "spot got very very warm and started to itch, hot and itching/very warm spot, the spot on her back was hot and itching and tingling, skin rubbed off" were downgraded to non-serious, the events "she thought the spot on her back was due to her movement with the material of the wrap with the cells in it, she put on the wrap all day and at night when she took off the thermacare wrap at night" were deleted.Follow-up (14jun2019): new information received from the same contactable consumer includes: additional medical history, product data (therapy dates, additional indication), concomitant medication, and event data (updated onset date and new event she was sleeping while wearing the product before the burning occurred/she attached the adhesive to body and clothing/she read directions, subsuming pruritus, feeling hot and paresthesia under burn).Follow-up (26jul2019): new information received from the same contactable consumer includes: additional medical history (postmenopausal and rheumatoid arthritis), updated past product history details, event details (experienced the burning, tingling-itching on her back hip (right)), duration for burning /tingling/ itching event (2 days).Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events thermal burns and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event skin exfoliation is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events thermal burns and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event skin exfoliation is non-serious.The events are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).Consumer alleges itching from wrap.The cause of the alleged itching is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Evaluation of the consumer's return sample did not provide any additional information as to why the wrap would caused itching; the alleged defective wrap worn by consumer was not returned.After a reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.The product quality for the batch is not impacted by this complaint.Severity ranking: s3 - serious, injury which could result in the need for medical treatment and hospitalization.
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Event Description
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Event verbatim [preferred term] burned like hell/the spot on her back was hot and itching and tingling [thermal burn] , she was sleeping while wearing the product before the burning occurred/she attached the adhesive to body and clothing/she read directions [intentional device misuse] , skin rubbed off [skin exfoliation] ,.Case narrative:this is a spontaneous report from a contactable consumer.This 67-year-old female consumer started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: w81909, expiration date jul2021) from (b)(6) 2019 to (b)(6) 2019 at unknown dose for back pain and hip pain.She was not pregnant.Medical history included rheumatoid arthritis, back and hip discomfort, war injury, aches and pains from being in the military, bad knees and she shrunk a little.The patient was post-menopausal.She was not currently under the care of a physician for any medical condition.Concomitant medication included camphor, eucalyptus globulus oil, menthol, syzygium aromaticum oil (tiger balm) for back and hip discomfort (after rinsing the area she waited until the next day and used tiger balm rub 1 dose daily).She also used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) from (b)(6)-(b)(6) 2019.She had not previously experienced a problem/ symptom with one of these products.She has previously used thermacare over the years and did not experience the same problem.She had had back pain from four years before and used the wraps all the time.She pulled a muscle in her hip many years before when she was in the military.Consumer purchased the heatwraps on (b)(6) 2019 and got the email telling her about the recall and she had already used the product and asked what to do now.She did notice where she put the thermacare heatwrap on her back that it activated a spot on her back.When she bought these thermacare heatwraps she put the wraps on her back where she normally placed them and got a very very warm spot that started to itch on her back.She thought the spot on her back was due to her movement with the material of the wrap with the cells in it.When asked whether it referred a product complaint that something wrong with the product caused events, she clarified she noticed a burning feeling on her back (right side) in (b)(6) 2019 (reported as (b)(6)-(b)(6) 2019).She took the heatwrap off.Later in the day the burning turned to stinging.Later in the night into the next day she had an itching feeling in (b)(6) 2019 where the burning and tingling was.She also reported the location of the burning, itching-tingling as on her "back hip (right)." she stated the thermacare wrap heated and she threw it away and then put another one on a couple of days later and the same spot on her back started itching again.She did not go to the hcp because it was not a thing and she did not notice her skin falling off or hair falling off or a burnt spot; she did not notice these things.The spot on her back was hot and itching and tingling for a while and first it tingled and later on when it cooled off it started itching and she thought maybe her clothes had irritated the same spot.She was out doing yardwork on the friday before mother's day this year and noted the spot on her back somewhere around that time and it had now completely resolved.The spot was little and only lasted a couple of times because she put on the wrap all day (she clarified that she used it up to the 8 hr) and at night when she took off the thermacare wrap at night she took a shower and noted it burned like hell and she thought her skin rubbed off (in (b)(6) 2019).She stated in her shower when the hot water hit the spot it burned but she did not realize it may be related to the heatwrap because she had never had an issue before.She was asked if she had treatment for the adverse event and stated she did and because she was feeling so itchy she put on antibiotic cream and benadryl on it and stated none of that helped the itchiness.She clarified she did not take benadryl but instead only used cortisone 10.She took everything out of the box because the box was bulky and applied the heatwrap on monday.She stated this showed how bad her back was and she had always used the thermacare heatwraps and used them when she was in the military many years before.She was not hospitalized due to events hot and itching and tingling.She had another (brand name) heatwrap and the (brand name) brand and the thermacare brands were the only ones that help her back pain which was an old war injury.She was asked for any other heatwraps that did not help her back pain and she stated the (brand name) and thermacare brands were the only two she had used and she was in the army for 22 years and hurt sometimes from her old wounds.She had used (brand name) muscle patches and tiger balm patches and a cheaper version of an absorbing patch but stated they were all just ok in terms of her back pain.She got these thermacare heatwraps on (b)(6) 2019 and there were two boxes and each box had two wraps in each box.She had no other lot numbers, expiry dates or upc/udi numbers to provide and she only had the one wrap left that she applied.She classified her skin tone as dark or olive.She denied sensitive skin or any abnormal skin conditions.The color of the box she purchased was red.There were some products remaining.She was sleeping while wearing the product before the burning occurred.She attached the adhesive to body and clothing.She read directions.She engaged in house work while using the product.She checked her skin under the product while wearing thermacare when she felt the burning on her hip and back.The action taken in response to the events of the product was stopped on (b)(6) 2019.The outcome of burn, hot and itching, tingling was resolved in 2019.The symptoms lasted for 2 days.The outcome of other events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).Consumer alleges itching from wrap.The cause of the alleged itching is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Evaluation of the consumer's return sample did not provide any additional information as to why the wrap would caused itching; the alleged defective wrap worn by consumer was not returned.After a reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.The product quality for the batch is not impacted by this complaint.Severity ranking: s3 - serious, injury which could result in the need for medical treatment and hospitalization.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: the events "spot got very very warm and started to itch, hot and itching/very warm spot, the spot on her back was hot and itching and tingling, skin rubbed off" were downgraded to non-serious, the events "she thought the spot on her back was due to her movement with the material of the wrap with the cells in it, she put on the wrap all day and at night when she took off the thermacare wrap at night" were deleted.Follow-up (14jun2019): new information received from the same contactable consumer includes: additional medical history, product data (therapy dates, additional indication), concomitant medication, and event data (updated onset date and new event she was sleeping while wearing the product before the burning occurred/she attached the adhesive to body and clothing/she read directions, subsuming pruritus, feeling hot and paresthesia under burn).Follow-up (26jul2019): new information received from the same contactable consumer includes: additional medical history (postmenopausal and rheumatoid arthritis), updated past product history details, event details (experienced the burning, tingling-itching on her back hip (right)), duration for burning /tingling/ itching event (2 days).Follow-up attempts are completed.No further information is expected.Follow-up (30jul2019): new information received from the product quality complaint group includes: severity ranking of s3.Follow-up (20aug2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment: based on the information provided, the events thermal burns and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event skin exfoliation is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events thermal burns and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event skin exfoliation is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).Consumer alleges itching from wrap.The cause of the alleged itching is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Evaluation of the consumer's return sample did not provide any additional information as to why the wrap would caused itching; the alleged defective wrap worn by consumer was not returned.After a reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request, for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Site sample status: received at the site.Date samples were received: (b)(6) 2019.Return sample evaluation: one lbh pouch - pouch is opened by consumer, no obvious defects.(l) w81909 08/06; exp 2021 03:43.
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Event Description
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Event verbatim [preferred term] burned like hell/the spot on her back was hot and itching and tingling [thermal burn], she was sleeping while wearing the product before the burning occurred/she attached the adhesive to body and clothing/she read directions [intentional device misuse], skin rubbed off [skin exfoliation], , narrative: this is a spontaneous report from a contactable consumer.This 67-year-old female consumer started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: w81909, expiration date jul2021) from (b)(6) 2019 at unknown dose for back pain and hip pain.She was not pregnant.Medical history included rheumatoid arthritis, back and hip discomfort, war injury, aches and pains from being in the military, bad knees, old wounds and she shrunk a little.The patient was post-menopausal.She was not currently under the care of a physician for any medical condition.Concomitant medication included camphor, eucalyptus globulus oil, menthol, syzygium aromaticum oil (tiger balm) for back and hip discomfort (after rinsing the area she waited until the next day and used tiger balm rub 1 dose daily), and other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) from (b)(6) 2019.She had not previously experienced a problem/ symptom with one of these products.She has previously used thermacare over the years and did not experience the same problem.She had had back pain from four years before and used the wraps all the time.She pulled a muscle in her hip many years before when she was in the military.Consumer purchased the heatwraps on (b)(6) 2019 and got the email telling her about the recall and she had already used the product and asked what to do now.She did notice where she put the thermacare heatwrap on her back that it activated a spot on her back.When she bought these thermacare heatwraps she put the wraps on her back where she normally placed them and got a very very warm spot that started to itch on her back.She thought the spot on her back was due to her movement with the material of the wrap with the cells in it.When asked whether it referred a product complaint that something wrong with the product caused events, she clarified she noticed a burning feeling on her back (right side) in (b)(6) 2019 (reported as (b)(6) 2019.She took the heatwrap off.Later in the day the burning turned to stinging.Later in the night into the next day she had an itching feeling in may2019 where the burning and tingling was.She also reported the location of the burning, itching-tingling as on her "back hip (right)." she stated the thermacare wrap heated and she threw it away and then put another one on a couple of days later and the same spot on her back started itching again.She did not go to the hcp because it was not a thing and she did not notice her skin falling off or hair falling off or a burnt spot; she did not notice these things.The spot on her back was hot and itching and tingling for a while and first it tingled and later on when it cooled off it started itching and she thought maybe her clothes had irritated the same spot.She was out doing yardwork on the friday before mother's day this year and noted the spot on her back somewhere around that time and it had now completely resolved.The spot was little and only lasted a couple of times because she put on the wrap all day (she clarified that she used it up to the 8 hr) and at night when she took off the thermacare wrap at night she took a shower and noted it burned like hell and she thought her skin rubbed off (in may2019).She stated in her shower when the hot water hit the spot it burned but she did not realize it may be related to the heatwrap because she had never had an issue before.She was asked if she had treatment for the adverse event and stated she did and because she was feeling so itchy she put on antibiotic cream and benadryl on it and stated none of that helped the itchiness.She clarified she did not take benadryl but instead only used cortisone 10.She took everything out of the box because the box was bulky and applied the heatwrap on monday.She stated this showed how bad her back was and she had always used the thermacare heatwraps and used them when she was in the military many years before.She was not hospitalized due to events hot and itching and tingling.She had another (brand name) heatwrap and the (brand name) brand and the thermacare brands were the only ones that help her back pain which was an old war injury.She was asked for any other heatwraps that did not help her back pain and she stated the (brand name) and thermacare brands were the only two she had used and she was in the army for 22 years and hurt sometimes from her old wounds.She had used (brand name) muscle patches and tiger balm patches and a cheaper version of an absorbing patch but stated they were all just ok in terms of her back pain.She got these thermacare heatwraps on 24apr2019 and there were two boxes and each box had two wraps in each box.She had no other lot numbers, expiry dates or upc/udi numbers to provide and she only had the one wrap left that she applied.She classified her skin tone as dark or olive.She denied sensitive skin or any abnormal skin conditions.The color of the box she purchased was red.There were some products remaining.She was sleeping while wearing the product before the burning occurred.She attached the adhesive to body and clothing.She read directions.She engaged in house work while using the product.She checked her skin under the product while wearing thermacare when she felt the burning on her hip and back.The action taken in response to the events of the product was stopped on 15may2019.The outcome of "burned like hell/the spot on her back was hot and itching and tingling" was resolved in 2019.The symptoms lasted for 2 days.The outcome of other events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).Consumer alleges itching from wrap.The cause of the alleged itching is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Evaluation of the consumer's return sample did not provide any additional information as to why the wrap would caused itching; the alleged defective wrap worn by consumer was not returned.After a reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request, for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Site sample status: received at the site.Date samples were received: 07jun2019.Return sample evaluation: one lbh pouch - pouch is opened by consumer, no obvious defects.(l) w81909 08/06; exp 2021 03:43.Severity ranking: s3 - serious, injury which could result in the need for medical treatment and hospitalization.Amendment: this follow-up report is being submitted to amend previously reported information: the events "spot got very very warm and started to itch, hot and itching/very warm spot, the spot on her back was hot and itching and tingling, skin rubbed off" were downgraded to non-serious, the events "she thought the spot on her back was due to her movement with the material of the wrap with the cells in it, she put on the wrap all day and at night when she took off the thermacare wrap at night" were deleted.Follow-up (14jun2019): new information received from the same contactable consumer includes: additional medical history, product data (therapy dates, additional indication), concomitant medication, and event data (updated onset date and new event she was sleeping while wearing the product before the burning occurred/she attached the adhesive to body and clothing/she read directions, subsuming pruritus, feeling hot and paresthesia under burn).Follow-up (26jul2019): new information received from the same contactable consumer includes: additional medical history (postmenopausal and rheumatoid arthritis), updated past product history details, event details (experienced the burning, tingling-itching on her back hip (right)), duration for burning /tingling/ itching event (2 days).Follow-up (30jul2019 and 20aug2019): new information received from the product quality complaint group includes: severity ranking of s3 and product quality investigation results.Follow up (14sep2020): new information received from the product quality complaint group included return sample evaluation., comment: based on the information provided, the events thermal burns and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event skin exfoliation is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.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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