It was reported through a legal event that a 64 year old patient had hernia repair surgery on or about on (b)(6) 2014.During the hernia repair surgery, the surgeon implanted two strattice meshes; lot#: s11253-091; ref#: (b)(4); mesh and lot#: s1273-014 ;ref#: (b)(4).After surgery, the patient returned to the hospital on or about on (b)(6) 2014, for a revision and removal surgery.No other information was provided.This record is associated with the second device implanted, s1273-014 ; ref#: (b)(4); however this is not a valid lot number and has been defaulted to unknown.This is the same event and the same patient reported under mdr#: 1000306051-2023-00087 (abbvie complaint#: (b)(4).
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This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.Internal investigation into strattice lot: s11253 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 17 april 2023, of the 194 devices released to finished goods for lot: s11253, 187 have bee distributed with 118 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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