Please note the corrections made to the d1 product long description, d2b product code.The reported event was not confirmed since the device was not returned for evaluation and no other evidences were provided.The visual inspection of the available picture confirmed the device identification.There is no visual defect on the device, but with only one picture, it¿s difficult to confirm the integrity of the device, and the reason of the revision.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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