On 16-dec-2022, a spontaneous report from social media was received regarding a female (age not provided) who used a thermacare heat wrap.Medical history and concomitant products were not provided.On an unspecified date, the consumer topically applied a thermacare heat wrap for an unknown indication.On an unspecified date, after applying a heat wrap, the consumer experienced having 4 huge blisters.The consumer noted they would not use the product again.No additional information was provided.
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The root cause cannot be identified.There is limited device specific information provided, no batch number or product type was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend was identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of blisters and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.
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