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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.The lot number (6050537) was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.
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Titan pump, cylinders 1 and 2, and detached connector / inlet tubing were received for evaluation.No functional abnormalities were noted with the pump.No functional abnormalities were noted with neither cylinder 1 nor cylinder 2.No functional abnormalities were noted with the detached connector or inlet tubing.The information received indicated that the patient wanted a different implant size, and the device was in poor position, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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