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 investigation.As no lot # was provided, a review of the device history record, complaint history database, nonconformance's and capas could not be completed.Device was received, and the condition of the device received indicated that the device was received to the pathology department in formalin.According to instruction, devices are not to be stored in formalin or other aldehyde-containing antiseptics, disinfectants or antimicrobials.Devices received in prohibited substances will not be evaluated by coloplast due to safety concerns.Therefore, this device receipt has been logged as received, but the device has been discarded and testing will not be performed.
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