BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA® MILTEX®

    MDR report key: 23671471 · Received November 28, 2025

    Report

    Report Number
    23671471
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 12, 2025
    Manufacturer
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    WOUND CARE REPORTS THAT A 3MM CURETTE HAS A METAL SHAVING ATTACHED THAT COULD DETACH INTO A PATIENT'S WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266411 INTEGRA® MILTEX® CURETTE, SURGICAL, GENERAL USE FZS INTEGRA LIFESCIENCES PRODUCTION CORPORATION 33-53 250105

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown