Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 03jul2019.Investigation ¿ evaluation.A review of the complaint history, device history record, instructions for use (ifu), and quality control of the device, as well as a visual inspection, were conducted during the investigation.The complainant returned two unopened ultrathane mac-loc locking loop multipurpose drainage sets to cook for investigation.Physical examination of the returned devices showed no perforation can be found on the trays.For one tray a small faint scratch mark can be found on the front of the package, but the package remains sealed.No other damage is noted to the trays.Because both trays are not perforated the complaint cannot be confirmed on the returned devices.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record for this lot found no related non-conformances.A review of reporting software found no other complaints reported for this lot.It was concluded that there is no evidence that nonconforming product exists in house or in field.Based on the information provided, inspection of returned product and the results of the investigation, no problem was detected with the device.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification and found no perforations on the device trays.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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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