Model Number ThermaCare HeatWraps - Muscle & Joint |
Device Problem
Excessive Heating (4030)
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Patient Problems
Burning Sensation (2146); Skin Tears (2516)
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Event Type
Injury
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Manufacturer Narrative
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The root cause cannot be identified.There was limited device-specific information provided, not batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for the product "the consumer experienced feeling that the product burns extremely bad".A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
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Event Description
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On 23-apr-2021, a spontaneous report was received from a consumer via a pharmaceutical company (reference number: 13927808) regarding a female consumer (age not reported) who used the thermacare menstrual 8hr 3ct heat wrap (lot number: 496668, expiration date: 13-may-2022).Medical history and concomitant products were not provided.On an unspecified date, on or before 13-feb-2021, the consumer topically applied the thermacare menstrual 8hr 3ct heat wrap for an unspecified indication to her stomach.On an unspecified date after applying the product, the consumer experienced feeling that the product burns extremely bad.When the product was pulled off it peeled her skin off.It was further clarified as, it took a layer of her skin off.No additional information was provided.Multiple follow up attempts were initiated but were unsuccessful.
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Search Alerts/Recalls
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