On (b)(6) 2022, a spontaneous report was received via social media regarding a thermacare menstrual 8hr heat wrap.Medical history included stomach cramps.Concomitant products were not provided.On an unspecified date, the consumer applied a thermacare menstrual 8hr heat wrap for stomach cramps.On an unspecified date, after applying the heat wrap, the heat wrap "broke open and burnt her tummy".She had a scar at the site.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 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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