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 additional device and event information, and the conclusion of the investigation.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.
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