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

Catalog Number	2020002
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Integrity Problem (2978)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	02/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qa investigation into lot sp100237 resulted in no remarkable findings and no deviations and no nonconfromances revealed.254 devices were released to finished goods and 187 have been distributed.Of the 187 distributed, 158 have been reported as implanted.Lot sp100237 was terminally sterilized and met all qc release criteria including mechanical testing.
Event or Problem Description
Patient underwent spigelian hernia repair surgery.Surgeon implanted strattice mesh (lot/batch: sp100237-231, catalog/reference #: 2020002).Approximately 3.5 years later,patient returned to the hospital and was diagnosed with a seroma and nonintegrated biologic abdominal reinforcement matrix.Surgeon noticed that the mesh split in half requiring removal.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• MDR Report Key: 11379832
• Report Number: 1000306051-2021-00013
• Device Sequence Number: 3773922
• Product Code: FTM
• UDI-Device Identifier: 00818410010140
• UDI-Public: 00818410010140
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• 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 Expiration Date: 03/31/2017
• Device Catalogue Number: 2020002
• Device Lot Number: SP100237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/25/2021
• 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
• Patient Age: 61 YR