On (b)(6) 2022, a spontaneous report from the united states was received via email regarding female consumer (age not provided) who used a thermacare lower back and hip heat wrap.Medical history included extreme back pain.Additional medical history and concomitant products were not provided.On an unspecified date, the consumer topically applied a thermacare lower back and hip heat wrap over a tank top.An hour after application, she felt stinging.She removed the wrap and found a burn about the size of a quarter.She noted that she followed the directions on the package.The burn was extremely painful on the top of her back.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 or return sample, 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 proceduresw hich include in process testing, thermal testing and visual inspection, to ensure packaged product quality.
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