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Catalog Number 1620002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hernia (2240)
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Event Date 03/26/2012 |
Event Type
Injury
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Manufacturer Narrative
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This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
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Event Description
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It was reported through a legal event that a (b)(6) year old female patient underwent hernia repair surgery on or about (b)(6) 2011.During the hernia repair surgery, the surgeon implanted two strattice meshes.The records indicate these were a strattice firm 16 x 20 and strattice firm 6 x 16 mesh.After surgery, the patient had several revision surgeries including: (b)(6) 2012, during which a strattice firm 10 x 16 mesh was implanted, (b)(6) 2014, revision surgery during which a strattice firm 16 x 20 mesh was implanted and (b)(6) 2015, surgery during which a strattice firm 20 x 40 mesh was implanted.This record is associated with the first strattice firm 16 x 20 implanted on (b)(6) 2011.Record 1 of 5.
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Event Description
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This is follow up #1 to report on july 25th, 2022, pmqa received notification from legal that the lots associated with this event were found through discovery and are s10867-051 and s10811-073.No other information was provided.This record is associated with s10867-051.Refer to medwatch 1000306051-2022-00052 for the investigation associated with s10811-073.As reported in the initial: it was reported through a legal event that a 63 year old female patient underwent hernia repair surgery on or about on (b)(6) 2011.During the hernia repair surgery, the surgeon implanted two strattice meshes.The records indicate these were a strattice firm 16 x 20 and strattice firm 6 x 16 mesh.After surgery, the patient had several revision surgeries including: on (b)(6) 2012, during which a strattice firm 10 x 16 mesh was implanted, on (b)(6) 2014, revision surgery during which a strattice firm 16 x 20 mesh was implanted and on (b)(6) 2015, surgery during which a strattice firm 20 x 40 mesh was implanted.This record is associated with the first strattice firm 16 x 20 implanted on (b)(6) 2011.Record 1 of 5.
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Manufacturer Narrative
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Additional and/or corrected data.Internal investigation into strattice lot: s10867 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 08/04/2022, of the (b)(4) devices released to finished goods for lot: s10867, (b)(4) were distributed with 162 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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Search Alerts/Recalls
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