The root cause cannot be identified.There is limited device specific information provided, no batch number 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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On (b)(6) 2022, a spontaneous report from the us was received via social media regarding a female (age not provided) who used an unspecified thermacare heat wrap.Medical history and concomitant products were not provided.On an unspecified date, the consumer used a thermacare heat wrap for an unknown indication.On an unspecified date, approximately 3 minutes after the consumer used a thermacare heat wrap, she felt burning.She noted she got burned and remarked, "never again." no additional information is expected as no contact information was provided.
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