According to available information, this device required replacement due to size and position.The distal end of the device was around 5 cm from the glands and not seated properly at the distal end of the penis.Due to the placement of the device, the device was rendered non-usable.The device was fully functioning.No other adverse patient effects were reported.
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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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