The root cause cannot be identified.The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records and production controls met the product release criteria.Consumer reports she "noticed there was black on the inside of it.The consumer noted it looked like one of the little pads had been leaking stuff on the heat wrap." without the physical sample for evaluation, the root cause of the consumer reporting she "noticed there was black on the inside of it.The consumer noted it looked like one of the little pads had been leaking stuff on the heat wrap" cannot be determined.The sample is not available for evaluation by the manufacturing site.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.
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