MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL

Catalog Number	2025002
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qa investigation into lot sp100477 resulted in no remarkable findings and no deviations and no nonconformance revealed.210 devices were released to finished goods and 139 have been distributed.Of the 139 distributed, 79 have been reported as implanted no other complaints against the lot sp100477 were revealed.Lot sp100477 was aseptically processed, terminally sterilized and met all qc release criteria.
Event or Problem Description
Patient representative reported a male patient had strattice, 2025002, implanted on (b)(6) 2017 for a ventral hernia repair.Patient was hospitalized on (b)(6) 2018 and a revision surgery took place for a bowel obstruction and hernia revision on b)(6) 2018.Lot number sp100477-004.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 11968061
• Report Number: 1000306051-2021-03004
• Device Sequence Number: 3604769
• Product Code: FTM
• UDI-Device Identifier: 00818410010157
• UDI-Public: 00818410010157
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 2025002
• Device Lot Number: SP100477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/09/2021
• 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