According to available information, this device required revision due to urinary retention.The patient had a small portion of the left device arm was excised to release the tension of the device.Immediately post-op, the patient was able to void completely and passed her active void trial.No other adverse patient effects were reported.
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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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