The root cause and root cause sub class cannot be identified.There was limited device-specific information provided, no 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 a burn and a risk calculation cannot be determined as there is no known batch number to identify if there were a device malfunction.
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On 22-jan-2024, a spontaneous report from the united states was received via email regarding a female consumer (age not provided) who used a thermacare neck/shoulder/wrist heat wrap.On an unspecified date, the consumer topically applied a thermacare neck/shoulder/wrist heat wrap for an unspecified duration of time for an unknown indication.On an unspecified date, the consumer experienced a burn.Further details not provided.
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