Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation reviews of the complaint history, device history record, documentation, manufacturer¿s instructions, and quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device revealed a hair-like fiber present inside the packaging.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that the failure mode can be attributed to the manufacturing and packaging of the device.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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