The root cause cannot be identified.The manufacturing site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports "she experienced a burning sensation and a blister".The cause of the consumer stating "she experienced a burning sensation and a blister" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of blisters or other skin irritations.This is an adverse event for a burning sensation and a blister; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
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On 22-mar-2022, a spontaneous report from the united states was received from a consumer via telephone regarding a (b)(6) african american female who used a thermacare lower back and hip 8hr l/xl heat wrap.Medical history included high blood pressure and type ii diabetes.The consumer was allergic to seafood and was a non-smoker.Concomitant products included metformin and hydrochlorothiazide.At 6:00 on (b)(6) 2022, the consumer topically applied a thermacare lower back and hip 8hr l/xl heat wrap to her lower back for an unspecified indication.At 16:00 on (b)(6)2022, the consumer took the heat wrap off.She experienced a burning sensation and a blister.For treatment she washed the area with warm water with soap and applied neosporin.She worked at a healthcare facility and the nurses where she worked advised her to use over-the-counter (otc) burn cream.Subsequently, she had been applying neosporin and an otc burn cream.As of (b)(6 )2022, the area was much better, and she no longer had the blister or burning pain.The area where the device was placed was still pinkish and it was resolving.She did not seek medical attention.No additional information was provided.
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