The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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.
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According to available information, this device required revision due to compromised corpora.The patient had preexisting conditions that caused a weakened corpora.During implant, the patient's corpora became compromised on one side.The device was implanted on the other side.The patient later had a revision to have the device placed on the previously compromised side.No other adverse patient effects were reported.
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