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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 04/03/2013 |
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 had hernia repair surgery on or about (b)(6) 2012.During the hernia repair surgery, the surgeon implanted a strattice firm mesh.The patient had a revision surgery on (b)(6) 2013, during which an additional strattice mesh was implanted.After these surgeries, the patient returned to the hospital for a revision surgery on (b)(6) 2014, during which strattice mesh was explanted.This record is associated with the strattice device implanted on (b)(6) 2012.
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Manufacturer Narrative
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Internal investigation into strattice lot s11071 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 08/01/2022, of the (b)(4) devices released to finished goods for lot: s11071, (b)(4) have been distributed with (b)(4) 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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Event Description
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This is follow up #1 to report on july 25th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is s11071-144.No other information was reported.As reported in the initial: it was reported through a legal event that a 47 year old female patient had hernia repair surgery on or about on (b)(6) 2012.During the hernia repair surgery, the surgeon implanted a strattice firm mesh.The patient had a revision surgery on (b)(6) 2013, during which an additional strattice mesh was implanted.After these surgeries, the patient returned to the hospital for a revision surgery on (b)(6) 2014, during which strattice mesh was explanted.This record is associated with the strattice device implanted on (b)(6) 2012.
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Search Alerts/Recalls
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