Model Number 2020005 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Ischemia (1942); Nausea (1970); Pain (1994); Seroma (2069); Swelling (2091); Vomiting (2144); Hernia (2240)
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Event Date 05/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).- review of lot processing history and complaint history records for lot sp100288 was unremarkable.There were no processing deviations or nonconformance related to the nature of this complaint and the lot met qc criteria for release, including mechanical testing results.- as of 06/22/2017, no other complaints involving serious injury were reported to lifecell against lot sp100288.- as of 06/22/2017, of the (b)(4) devices released to finished goods for lot sp100288, (b)(4) devices were distributed with (b)(4) devices reported to be implanted.Evaluation conclusion: (b)(4).- the event is unlikely related to strattice laparoscopic mesh and likely related to the patient's condition, including history of large mesenteric defect with incarcerated small bowel, colon cancer, hemicolectomy, hyperlipidemia, smoking dependence, and that the interoperative findings revealed the recently placed hernia mesh was intact.Based on our internal review of the device processing history, the lot met qc criteria for product release, including mechanical testing.No similar complaint was reported against the lot.The lot was aseptically processed and terminally sterilized within process parameters.There was no nonconformance or deviations encountered in association with the event.Device not returned for evaluation.
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Event Description
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It was initially reported that the strattice mesh was explanted from the patient 48 hours after implantation due to complications.On follow up, it was reported that a (b)(6) male patient underwent ventral hernia laparoscopic repair with strattice laparoscopic on (b)(6) 2017.On (b)(6) 2017, at bedside, the patient complained of abdominal pain, developed some nausea, and began vomiting with increasing pain.The patient was also reported to be passing gas and having bowel movements.The surgeon was initially concerned that a section of bowel was trapped between the mesh and the abdominal wall, as the patient clinically presented like obstruction.Following a ct scan, the patient was returned to the or for exploratory laparotomy, reduction of internal hernia, hernia mesh explantation, complex layered ventral hernia repair, open liver biopsy, and negative pressure dressing.Operative findings: hernia mesh recently placed was intact.Seroma was present.Given the hostility of the abdomen, the mesh had to be removed.The pathology was encountered at the previously made anastomosis from the right colon resection where there was a large mesenteric defect with incarcerated small bowel.Additionally, there was a large palpable hepatic mass on inspection of the liver.Post operative diagnosis includes large internal hernia with ischemic small bowel, postoperative seroma and hepatic mass.On (b)(6) 2017, the patient was discharged.
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Search Alerts/Recalls
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