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Catalog Number 2030002 |
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 08/23/2016 |
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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Limited information was reported through a legal event, that a (b)(6) patient underwent hernia repair surgery on or about (b)(6) 2013.During the hernia repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2016, for a revision surgery.
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Manufacturer Narrative
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Internal investigation into strattice lot s11252 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 9/22/22, of the (b)(4) devices released to finished goods for lot s11252, 136 have been distributed with 79 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.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 on september 13, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is s11252-045.No other information was reported.As reported in the initial: limited information was reported through a legal event, that a 48 male patient underwent hernia repair surgery on or about (b)(6) 2013.During the hernia repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2016, for a revision surgery.
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Search Alerts/Recalls
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