Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device will not be returned.
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According to the available information, though not verified, reported complaint: "physician was beginning to tension altis when suture broke (dynamic anchor).Normal implantation and tensioning was completed.Broken altis was removed and new altis successfully implanted." product not returning.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.
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