MAUDE Adverse Event Report: STRATTICE PERFORATED 20 X 20; MESH, SURGICAL

Catalog Number	2020002P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The internal investigation into strattice lot sp100295 included a review of the reported information, review of the device history records and review of the complaint history records.The device was not returned to lifecell for evaluation.Investigation results revealed no remarkable findings with no similar complaints reported against the lot and no related deviations or nonconformances revealed during processing associated with the nature of the event.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, of the 158 devices released to finished goods for lot sp100295, 151 have been distributed.No further actions are required as a nonconformance could not be confirmed.
Event or Problem Description
It was reported that a (b)(6) male underwent a ventral/umbilical hernia repair on (b)(6) 2013 and was implanted with strattice lot s11301-041.Two years after the surgery, the patient returned to the hospital on or about (b)(6) 2015 and was diagnosed with a partial small bowel obstruction.The patient had a release of partial small bowel obstruction, repair of recurrent ventral/umbilical hernia and removal of old mesh at medical west hospital performed by dr.Issis.The patient was implanted with another piece of strattice, lot sp100295-142.After surgery, the patient returned to the hospital on january 7th, 2016 and was diagnosed with small bowel obstruction.On (b)(6) 2016, the patient had a release of small bowel obstruction, release of internal hernia and excision of strattice mesh a medical west hospital.This record is associated with the second reported lot, sp100295-142.

• Brand Name: STRATTICE PERFORATED 20 X 20
• Common Device Name: MESH, SURGICAL
• MDR Report Key: 12161083
• Report Number: 1000306051-2021-03026
• Device Sequence Number: 11690681
• Product Code: FTM
• UDI-Device Identifier: 00818410012311
• UDI-Public: 00818410012311
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2020002P
• Device Lot Number: SP100295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention