MAUDE Adverse Event Report: STRATTICE LAPAROSCOPIC 16CM X 20CM; MESH, SURGICAL

Catalog Number 1620005

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hernia (2240)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

An investigation into lot sp100288 resulted in no remarkable findings and no processing deviation and no nonconformance's revealed.Lot sp100288 was aseptically processed, terminally sterilized and met all qc release criteria.There were two other unrelated complaints reported for this lot.As of (b)(6) 2021, of the (b)(4) devices released to finished goods for lot sp100288, (b)(4) have been distributed.Of the (b)(4) distributed, (b)(4) have been reported as implanted.

Event Description

It was reported that the patient underwent hernia repair surgery at (b)(6) medical center on (b)(6) 2015 and was implanted with strattice.The patient returned to the hospital on (b)(6) 2016 for further surgery because the strattice device failed by not adhering to the patient's abdominal wall and allowing a hernia recurrence.The patient's strattice was not removed during this procedure and instead another strattice lot was placed, (b)(4).The patient returned to the hospital on (b)(6) 2020 because the strattice mesh failed again.Among other things, it contracted, failed to adhere to the patient's abdominal wall, wadded up, and allowed the patient's bowel to hernia through the mesh repair.The patient required surgery to remove the strattice and repair the defect.This record is associated with the second strattice lot implanted, (b)(4), record 2 of 2.

• Brand Name: STRATTICE LAPAROSCOPIC 16CM X 20CM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12206409
• MDR Text Key: 276919679
• Report Number: 1000306051-2021-03041
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1620005
• Device Lot Number: SP100288
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention