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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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Two cylinders were received for evaluation.Examination of the returned components revealed no abnormalities that would have contributed to the report of incorrect sizing.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconformances revealed no nonconformance with this lot that would have contributed to the event.However, because quality's examination of the returned components may not conclusively confirm or disprove the report of incorrect sizing, quality accepts the physician's observations of such as the reason for surgical intervention.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, and because the device is not available for evaluation, no further corrective action is required at this time.
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