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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 05/22/2014 |
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 fourth strattice firm 16 x 20 implanted on (b)(6) 2014.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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Manufacturer Narrative
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Additional information was received from legal that indicated the lot associated with this event was sp10053-012 however, the lot number is not valid and therefore, no internal investigation can be preformed.The lot associated with this event remains unknown.The conclusion remains the same.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.As reported in the initial: 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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This is follow up#1 to report that on july 25th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp10053-012.Although a lot number was reported, the lot number is not valid and the lot associated with this event remains unknown.No other information was provided.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 fourth strattice firm 16 x 20 implanted on (b)(6) 2014.Record 4 of 5.
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Search Alerts/Recalls
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