(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
The udi is unknown because the part number and lot number were not provided.
The device was not returned for evaluation.
A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.
Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
The investigation was unable to determine a conclusive cause for the reported difficulties.
The trek is filed under a separate medwatch manufacturer report reference number.
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