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The root cause category is non assignable (complaint not confirmed).Consumer reports "burned the caller's arm.The burn occurred under her left arm, near her underarm."after wearing a wrap.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the sub-class of cells damaged/leaking.This batch s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).This current complaint does not involve cell pack damage/leaking.
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Event verbatim [preferred term] burn/burned on her arm/ the burn was stinging [thermal burn] , she read the usage instructions before use/ she was sleeping while wearing the product/ she attached the adhesive to her arm, not clothing [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain, lot #s68516 and expiration date: jul2020) from an unspecified date to (b)(6) 2018, one wrap as needed, for arm pain.Medical history included high blood pressure and digestive problems, heartburn (when she ate sometimes) and osteoarthritis.The patient's concomitant medications included amlodipine, 5 milligrams, once per day, for high blood pressure.The patient previously used thermacare heatwrap not consistently and did not experience same problem/symptom below.Whenever she had pain, she would use thermacare for her back or arm, wherever she could use this particular patch.There was some for the back, and she has used this product.The patient previously used a heating pad and hot water for pain relief and did not experience any problem.It was very hard to use the hot water bottle on her arm because it was going to fall off.The heating pad was very large, and it was difficult to wrap it around there, so bought the thermacare.The patient started using thermacare heatwraps muscle pain therapy years ago.She found the product to be very good.She was calling because the product burned on her arm two and half weeks ago ((b)(6) 2018).She stated that she was reporting this because she was told there is a recall.The burn occurred under her left arm, near her underarm.At night, something kept bothering her: her underarm.When she got up, she took the patch off and saw that her arm looked sort of raw.She didn't go to her primary care provider; she treated the burn herself.She began using vaseline ointment on the burn.The burn was stinging.It wasn't hurting, but it was like something had bitten her.For the stinging, once she put vaseline on the next morning, it took away some of the stinging.It was still stinging but not as bad during the day.In the evening, she could not take a shower.She washed herself off but didn't want to bother the place where it was burning.She put more vaseline on there.The vaseline seemed to cool it down, so by that evening, when she went to bed again, she got a lot of relief from the vaseline.She verified that the stinging started when she noticed the burn.The patient also reported she fell in 2017 and her arms began to hurt her, really hurting.She went to the pharmacy, over-the-counter, and was looking around.She saw that this particular thermacare was on sale.She had used the product before and had a coupon for (b)(6) dollars.She clarified that she used the product because she fell on her arm and hurt her arm.She clarified that the fall was last year (2017), after she began using thermacare heatwraps muscle pain therapy in general.She was healing from the fall.She classifies her skin tone as medium.She really does not have sensitive skin.She does not have abnormal skin conditions.The color of the box she purchased was red box.No product remaining, product was discarded.She used the product for 3 nights in a row, 8 hours per day.When answered the question "did you check your skin under the product while wearing thermacare?" she replied that the first 2 nights she used the product, it was very comfortable for 8 hours.She had an alarm on, and she took the product off.The burn didn't happen with the first two patches but happened with the third patch.She read the usage instructions on thermacare before she used the product.She was sleeping while wearing the product.She had on pajamas.Her husband put it on for her.Nothing was supposed to be put over it.She attached the adhesive to her arm, not clothing.She was not wearing a snug waistband/belt or similar or otherwise applied pressure over the area.She went to bed, didn't engage in exercise while using the product.She did not consult a healthcare professional for the problem/symptom because she didn't think she needed to.The burn was still there if you look at her arm, but it was not raw like it was in the beginning.She was still putting vaseline on there, and it was healing nicely.The burn was still healing but not stinging any longer.She was given an doctor appointment on (b)(6) 2018.The action taken in response to the event for thermacare heatwrap was temporarily withdrawn on (b)(6)2018.The outcome of the events burn was resolving.The outcome of other event was unknown.The physician stated the patient did not provide information regarding the reported adverse events with the use of the product.The product quality group provided the following investigation summary: the root cause category is non assignable (complaint not confirmed).Consumer reports "burned the caller's arm.The burn occurred under her left arm, near her underarm."after wearing a wrap.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Investigation pr -2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the sub-class of cells damaged/leaking.This batch s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).This current complaint does not involve cell pack damage/leaking.Follow-up (04dec2018): new information from a contactable consumer includes: product lot number and expiration date.Follow-up (09jan2019): new information received from the product quality complaint group.Includes: investigation summary follow-up (10jan2019): new information received from a contactable physician included: new reporter.Follow-up (04dec2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: the above referenced lot number s68516 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020., comment: the above referenced lot number s68516 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
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