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Model Number 2020005
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Ischemia (1942); Nausea (1970); Pain (1994); Seroma (2069); Swelling (2091); Vomiting (2144); Hernia (2240)
Event Date 05/18/2017
Event Type  Injury  
Manufacturer Narrative
(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.
Event Description
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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Manufacturer (Section D)
one millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
one millennium way
branchburg, NJ 08876
MDR Report Key6662330
MDR Text Key78232465
Report Number1000306051-2017-00036
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2017
Device Model Number2020005
Device Catalogue NumberN/A
Device Lot NumberSP100288
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/22/2017 Patient Sequence Number: 1