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Catalog Number 2040002 |
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 05/21/2015 |
Event Type
Injury
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Event Description
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It was reported through a legal event that a (b)(6) 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 fifth strattice firm 20 x 40 mesh implanted on (b)(6) 2015.Record 4 of 5.
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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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Search Alerts/Recalls
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