BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE SHARP

    MDR report key: 12353998 · Received August 20, 2021

    Report

    Report Number
    MW5103405
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Report Date
    August 18, 2021
    Manufacturer
    XODUS MEDICAL INC.
    Product Code
    OCT
    UDI-DI
    00787551037029
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TAMPON OR TROCAR CLEANING DEVICE WHEN PLACED IN TROCAR THE PLASTIC FLAKED OFF TAMPON BUT THE FLAKES WERE RETRIEVED FROM TROCAR. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243730 SEE SHARP ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY OCT XODUS MEDICAL INC. 21JUL08 00787551037029

    Patients

    Seq Age Sex Outcome Treatment
    1