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Model Number 2025002P
Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)
Patient Problems Pain (1994); Discomfort (2330); Bowel Perforation (2668)
Event Date 12/25/2016
Event Type  Injury  
Manufacturer Narrative
Method of evaluation: manufacturing review: review of information as reported to lifecell, review of the device history records and complaint history records associated with lot sp100453. Results of evaluation: no failure detected: qa investigation into lot sp100453 resulted in no remarkable findings with no other complaints reported against the lot; as of 1/23/2017, of the (b)(4) devices released to finished goods for lot sp100453, (b)(4) devices have been distributed; lot sp100453 was terminally sterilized and met all qc release criteria, including mechanical testing results. Conclusion code: no failure detected. The reported coughing fit which occurred 9 days post-operatively and patient factors such as a history of multiple abdominal surgeries likely contributed to this patient's re-herniation and post-op tear. The ifu warns that potential adverse events typically associated with surgical mesh materials and their implantation procedures include a recurrence of tissue defects. The bowel perforation made by the skin staple is considered related to surgical technique. Qa investigation into lot sp100453 resulted in no remarkable findings. Lot sp100453 met all qc release criteria. The explanted device was not returned to lifecell. If the device is returned, a follow up report will be submitted. Based on the reported information and the results of the investigation, the event is unlikely related to the strattice device. Device not returned to manufacturer.
Event Description
It was reported that this is a male patient with a history of multiple abdominal surgeries. On (b)(6) 2016, the patient underwent an open abdominal hernia repair with component separation and strattice implanted in an underlay position to correct a recurrent hernia. The surgeon placed 0 pds sutures around the circumference of the trimmed mesh to properly secure the device to the rectus muscle. Closure of the rectus was achieved and drains were placed posteriorly to the rectus muscle and in the gutters between the subcutaneous skin flaps and the abdominal rectus. The midline skin incision was closed with staples. On (b)(6) 2016 (pod 9), the patient experienced a coughing fit and felt a popping sensation in the abdominal region followed by pain and discomfort. On (b)(6) 2016, the patient went to the hospital as the pain continued and felt like medical attention was needed. The nurse caring for the patient noticed fluid leaking at the inferior portion of the incision and contacted the implanting surgeon to notify him. Based on cultures taken, there was no infection, bile or gastric juices present. A ct scan was ordered and the mesh appeared to be in place. Eventually, the incision was opened at the point where the fluid was leaking and it was noticed that a very small piece of bowel was perforated by the skin staple, however the puncture was clean and appeared to be fresh. Subsequently, the patient was returned to surgery to address the complication. Intra-operatively, the surgeon found a moderately sized hole in the center of the strattice. The sutures were still intact and the rest of the mesh appeared healthy, however bowel had re-herniated through the medial aspect of the device. The strattice was explanted and the patient is currently recovering from surgery.
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Manufacturer (Section D)
one millennium way
branchburg NJ 08876
Manufacturer Contact
paul arrendell
one millennium way
branchburg, NJ 08876
MDR Report Key6280901
MDR Text Key65901551
Report Number1000306051-2017-00002
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 01/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2018
Device Model Number2025002P
Device Catalogue NumberN/A
Device Lot NumberSP100453
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/30/2016
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: 01/26/2017 Patient Sequence Number: 1