[146359779]
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.
Patient Sequence No: 1, Text Type: D, B5