MAUDE Adverse Event Report: LIFECELL STRATTICE PERFORATED 20 X 25; MESH, SURGICAL

Catalog Number	2025002P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qa investigation into lot sp100339 resulted in no processing deviations and 2 nonconformances (765926, 767457) related to the nature of this complaint.Ncr (b)(4)¿ strattice ¿ atmi mixer 200l sterile mixer bag leak.Product/patient impact is low.Ncr (b)(4)¿ 132p0119 ¿ bioburden tesing not performed on first shipment of pouches for the calendar year.Product/patient impact is low.(b)(4) devices were released to finished goods and (b)(4) have been distributed.Of the (b)(4) distributed, (b)(4) have been reported as implanted.Lot sp100339 was terminally sterilized and met all qc release criteria including mechanical testing.
Event or Problem Description
Patient underwent incisional hernia repair with strattice mesh (lot/batch: sp100339-159, catalog/serial: (b)(4)) implanted.3 years later, patient returned to hospital and was diagnosed with infected mesh, requiring removal.Mesh removed the same day.

• Brand Name: STRATTICE PERFORATED 20 X 25
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• MDR Report Key: 11675393
• Report Number: 1000306051-2021-00028
• Device Sequence Number: 3495234
• Product Code: FTM
• UDI-Device Identifier: 00818410012335
• UDI-Public: 00818410012335
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• 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: 12/31/2017
• Device Catalogue Number: 2025002P
• Device Lot Number: SP100339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/15/2021
• 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: 56 YR