BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKLAR STERILE TOE NAIL REMOVAL TRAY CS/10

    MDR report key: 8465718 · Received March 28, 2019

    Report

    Report Number
    MW5085375
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    March 26, 2019
    Report Date
    March 26, 2019
    Manufacturer
    UNK
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SKLAR STERILE TOENAIL REMOVAL TOENAIL REMOVAL TRAY CS/10 REORDER NUMBER (B)(4) IS NOT LABELED FOR SINGLE USE. MANUFACTURER HAS BEEN CONTACTED AND INSTRUMENTS HAVE BEEN VERIFIED AS SINGLE USE ONLY AND OUR CLINIC HAS HAD ISSUES WITH RE-STERILIZATION WHICH CAN POTENTIALLY LEAD TO AN ADVERSE EVENT. SKLAR CORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256016 SKLAR STERILE TOE NAIL REMOVAL TRAY CS/10 KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1