The device was not returned for evaluation.
A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.
Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.
The investigation was unable to determine a conclusive cause for the reported complaints since the device was not returned for analysis and limited information was provided.
There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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