BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA MILTEX

    MDR report key: 19971631 · Received August 13, 2024

    Report

    Report Number
    19971631
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 24, 2024
    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

    DISPOSABLE 5MM CURETTE HAD CURLED METAL SHAVING ATTACHED TO CIRCULAR METAL PORTION OF INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985474 INTEGRA MILTEX CURETTE, SURGICAL, GENERAL USE FZS INTEGRA LIFESCIENCES PRODUCTION CORPORATION 33-55 230920

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown