The product is expected to be returned, but has not yet been received.
Upon receipt and evaluation of the device a supplemental report will be submitted with the investigation findings.
The correct lot number was not provided; therefore, a review of the manufacturing records could not be completed.
Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
(b)(4).
|