BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBELIS VAGINAL MANIPULATOR SIZE 35-M

    MDR report key: 17202447 · Received June 23, 2023

    Report

    Report Number
    MW5118822
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 21, 2023
    Report Date
    June 21, 2023
    Manufacturer
    THE O R COMPANY PTY LTD
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VAGINAL MANIPULATOR BALLOON TORN WHEN ATTEMPTED TO BE RETRIEVED FROM PATIENT'S WOUND CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422056 OBELIS VAGINAL MANIPULATOR SIZE 35-M CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF THE O R COMPANY PTY LTD REF UE-OBPRO-35 2302036

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female