The lot number was reviewed for complaint trend, nonconforming reports and capa review.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 the available information, the patient reported feeling a bit uncomfortable.The reservoir was found to have been protruding a bit superficially, but was replaced with another reservoir.There was no functional defect reported with the prosthesis or reservoir.
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