Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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This follow-up mdr is created to document the evaluation of the returned device and corrected device information.A titan touch pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed no functional abnormalities with the pump, cylinder #1, or cylinder #2.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no additional complaints reported for lot 5708138.Review of nonconforming reports revealed no nonconformance's with this lot that would have contributed to the reported event.No capas for issues of this type are associated with this lot.The information received indicated a malfunction, the pump didn't work during the implant procedure, but because no functional abnormalities were noted with the returned components, quality cannot confirm the complaint as reported.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, no further corrective action is required at this time.
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