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Catalog Number 1525002 |
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 06/08/2020 |
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 male patient had hernia repair surgery on or about (b)(6) 2018.During the patient's hernia repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2020.The patient reported intermittent pain, difficulty breathing when hernia was protruding, and a decrease in his ability to perform his daily activities.He was diagnosed with recurrent incisional hernia.On or about (b)(6) 2020, the patient underwent a complex recurrent incisional hernia repair, lysis of adhesions of omentum and small bowel to strattice mesh, excision of abdominal wall foreign body, component separation, and placement of additional mesh.
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Manufacturer Narrative
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Additional and/or corrected data: b5, d4, g6, h2, h6.Internal investigation into strattice lot sp100523 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 10/12/2022, of the (b)(4) devices released to finished goods for lot sp100523, (b)(4) have been distributed.Of the (b)(4) distributed, (b)(4) have been 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 24, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100523-011.No other information was provided.As reported in the initial: it was reported through a legal event that a 74 year old male patient had hernia repair surgery on or about (b)(6) 2018.During the patient's hernia repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2020.The patient reported intermittent pain, difficulty breathing when hernia was protruding, and a decrease in his ability to perform his daily activities.He was diagnosed with recurrent incisional hernia.On or about (b)(6) 2020, the patient underwent a complex recurrent incisional hernia repair, lysis of adhesions of omentum and small bowel to strattice mesh, excision of abdominal wall foreign body, component separation, and placement of additional mesh.
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Search Alerts/Recalls
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