MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION INTEGRA MESHED BILAYER WOUND MATRIX SIZE 4X5; N/A

Catalog Number	MWM4051
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
Sales representative narrative: "procedure was oncologist excision of melanoma.Surgeon states graft "became infected" and had to be removed after placement.".
Event or Problem Description
Na.
Additional Manufacturer Narrative
The wound matrix (id mwm4051) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: INTEGRA MESHED BILAYER WOUND MATRIX SIZE 4X5
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ 08536
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21875744
• Report Number: 1121308-2025-00012
• Device Sequence Number: 7899248
• Product Code: KGN
• UDI-Device Identifier: 10381780032373
• UDI-Public: 10381780032373
• Combination Product (Y/N): N
• PMA/510(K) Number: K081635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: MWM4051
• Device Lot Number: 7387376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown