The device has not been returned to allergan for evaluation and it is unknown at this time if the strattice was removed.
Based on limited information, a relationship between the event and the strattice could not be determined.
Due to lack of information, strattice as a contributing factor cannot be ruled out.
Lifecell reports the event in abundance of caution.
Multiple attempts to obtain additional information are being made; however to date, no further information has been obtained our internal investigation of lot sp100512 includes a review of the reported information, a review of the device history results, and a review of the complaint history records.
The review processing history records for lot sp100512 was unremarkable.
The lot was aseptically processed and terminally sterilized within process parameters.
There were no processing deviations or nonconformance related to the nature of this complaint.
There was one unrelated complaint reported to allergan against lot sp100512.
As of (b)(6) 2018, of the 478 devices released to finished goods for lot sp100512, 473 have been distributed.
Of the 473 distributed, 137 have been reported as implanted.
Based on our internal review, lot sp100512 met qc criteria for release.
Should additional information be reported, a follow up adverse event report will be submitted.
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