MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION INTEGRA MESHED BILAYER WOUND MATRIX SIZE 8X10; DRESSING, WOUND, DRUG

Catalog Number	MWM8101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a patient with a 4th degree burn on the left lower extremity due to a motor vehicle collision.The initial application of an integra meshed bilayer wound matrix (id mwm8101) was on (b)(6) 2024.A localized infection was present underneath the graft.The matrix was removed on (b)(6) 2024, and reapplied on the same day.Surface area where product did not incorporate: 315 sq cm size of product required to reapply to surface area where product did not incorporate: 800 sq cm.
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.
Additional Manufacturer Narrative
The integra meshed bilayer wound matrix (id (b)(6)) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, the likely cause is the underlying condition on the patient.Integra lifesciences has process steps and testing in place to mitigate risk and is dedicated to manufacturing safe and effective product.Dhr review did not find any anomalies within the batch record.All manufacturing steps and processes were followed, and all testing met requirements per applicable procedures.There is no indication from the batch record review that the cmc plainsboro production process may have contributed to this complaint.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.
Event or Problem Description
N/a.

• Brand Name: INTEGRA MESHED BILAYER WOUND MATRIX SIZE 8X10
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19143916
• Report Number: 1121308-2024-00016
• Device Sequence Number: 15443785
• Product Code: FRO
• UDI-Device Identifier: 10381780032397
• UDI-Public: 10381780032397
• Combination Product (Y/N): N
• PMA/510(K) Number: K081635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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 Expiration Date: 01/31/2025
• Device Catalogue Number: MWM8101
• Device Lot Number: 7051082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2023
• 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
• Patient Sex: Unknown