BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE

    MDR report key: 743072 · Received June 15, 2005

    Report

    Report Number
    MW1035740
    Event Type
    Malfunction
    Date Received
    June 15, 2005
    Date of Event
    June 3, 2005
    Report Date
    June 8, 2005
    Manufacturer
    GYNECARE JETCO
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON ATTEMPTING TO PLUG INTO MACHINE IT WAS UNABLE TO BE INSERTED. UPON INSPECTION THE "PINS" WERE BENT. NO PT INJURY. BALLOON INFLATED BUT NOT INSERTED- EVENT OCCURRED DURING TESTING PHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE INTERNAL ABLATION MNB GYNECARE JETCO TC 003 UBM601

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR