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 pain.The patient was having pain in the proximal location.The doctor wanted to investigate and decided to re-position the device.The reservoir, cylinders and pump were retained.No other adverse patient effects were reported.
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