A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.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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This follow-up mdr is created to document the conclusion of the evaluation, the updated device information and updated method codes.No product was received for evaluation.As examination of the components may not conclusively confirm or disprove the report of crossover, quality accepts the physician's observations as to the reason for surgical intervention.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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