Investigation/evaluation: the investigation performed for this complaint report included a review of complaint history, the device history record, and specifications.A visual inspection of the returned device was also conducted during the investigation.One unopened package labeled rpn aus-035145-df, label lot number 8343216 was received.Visual examination of the package confirmed a dark color hair loose inside the sealed package.The device history record was reviewed and noted one related non-conformance during the manufacturing process for (1) item with foreign matter, loose.The item was reworked.A review of complaint history revealed this is the only reported complaint associated to complaint lot number 8343216.Based on the evidence presented by the sample, this event has been attributed to a manufacturing event.Additional measures have been initiated to address this failure mode.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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