This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.Internal investigation into strattice lot s11086 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 19 april 2023, all of the 168 devices released to finished goods for lot s11086 have been distributed with 9 reported as implanted.Based on our internal investigation with no remarkable findings, and without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
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It was reported through a legal event that a patient had hernia repair surgery on or about (b)(6) 2012 at (b)(6) medical center in (b)(6).During the hernia repair surgery, the surgeon implanted a strattice mesh product, lot number s11086-120.After surgery, the patient returned to the hospital on or about (b)(6) 2013 and underwent a mesh revision operation.No other information was reported.
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