BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE CORKSCREW

    MDR report key: 13140 · Received May 9, 1994

    Report

    Report Number
    MW1001895
    Event Type
    Malfunction
    Date Received
    May 9, 1994
    Date of Event
    February 7, 1994
    Report Date
    April 28, 1994
    Manufacturer
    WISAP
    Product Code
    HHO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE MYOMA DRILL, WHICH PREVIOUSLY WAS A TWO PART STAINLESS STEEL DEVICE, WITH THE SCREW PART FIXED TO THE ROD PART, IS NOW A SINGLE ROD PART, WITH THE DISTAL TIP MACHINED TO A SCREW ACTION. A SEPARATION, SUCH AS THE REPORTED EVENT, WILL THUS BE PREVENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTERINE CORKSCREW UTERINE CORKSCREW HHO WISAP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other