BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYTYVAC, M STYLE, MUSHROOM

    MDR report key: 1062577 · Received May 30, 2008

    Report

    Report Number
    1062577
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    January 8, 2008
    Report Date
    May 30, 2008
    Manufacturer
    COOPER SURGICAL
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER OBTAINING CONSENT FOR A VACUUM DELIVERY, THE MUSHROOM CUP MITYVAC WAS PLACED AND POSITION WAS CHECKED. OVER THE NEXT TWO CONTRACTIONS, THE PHYSICIAN DID ATTEMPT TO PULL WITH THE VACUUM AND THERE WAS ONE POP-OFF. THE VACUUM WAS NOT MAINTAINING ADEQUATE SUCTION BEYOND A LEVEL OF 10-15. THE VACUUM WAS REMOVED AND A NEW REPLACEMENT PUMP WAS OBTAINED AS WELL AS THE VACUUM CUP AND TUBING. THE NEW VACUUM WAS PLACED AND AGAIN POSITION WAS CHECKED. STEADY PROGRESS WAS MADE AND THE VACUUM WAS MAINTAINED AT APPROXIMATELY 45-50 IN THE GREEN ZONE AND THERE WERE NO POP-OFFS. THE CUP AND TUBING WAS NOT RETAINED AND THE LOT NUMBER WAS NOT RECORDED. EARLY THIS YEAR, A RECALL NOTICE WAS RECEIVED FROM COOPER SURGICAL REGARDING A RECALL OF SPECIFIC LOT NUMBERS OF THE DISPOSABLE VACUUM ASSISTED DELIVERY PRODUCTS. WE DID PULL FROM INVENTORY 12 ITEMS FROM ONE AFFECTED LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYTYVAC, M STYLE, MUSHROOM VACUUM ASSIST DEVICE, WITH VACUUM CUP, FETAL HDB COOPER SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *