MAUDE Adverse Event Report: Integra - Princeton 5ML DuraSeal single kit per box US; Dural Repair

Catalog Number	202010DS
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An authorized distributor reported that netcare akasia had an emergency craniotomy and they were called in for the case as there was an issue with the 5ml duraseal single kit per box us (202010ds) not drying after application.Upon inspection, the duraseal had been applied with the micromyst and even after 15 mins it still had not dried.Management was then informed immediately of the situation.The physician informed us that this can be a potential risk (infection) for the patient and future patients, so she will stop using the product until feedback is provided accordingly.There was increased surgery time of 15 minutes.
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.

• Brand Name: 5ML DuraSeal single kit per box US
• Common Device Name: Dural Repair
• Manufacturer (Section D): Integra - Princeton; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): Integra - Princeton; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50025150
• Report Number: 3003418325-2026-00021
• Device Sequence Number: 16096837
• Product Code: NQR
• UDI-Device Identifier: 10381780000013
• UDI-Public: 10381780000013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 202010DS
• Device Lot Number: 60713019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Micromyst
• Patient Sex: Unknown