The root cause and root cause sub class cannot be identified.There was limited device-specific information provided, not 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 heat cells damaged leaking.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 heat cells damaged leaking 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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