BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITY VAC

    MDR report key: 2220382 · Received August 17, 2011

    Report

    Report Number
    MW5021810
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 17, 2011
    Manufacturer
    COOPER SURGICAL
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS EXHAUSTED AND AGAIN QUITE COMMITTED TO A VAGINAL DELIVERY AND WAS OPEN TO A VACUUM DELIVERY. THE VACUUM WAS PLACED AND THE PT BEGAN TO PUSH AND THERE WAS NOT ANY MOVEMENT DETECTED. AT THIS POINT, IT WAS OBVIOUS THAT SHE NEEDED A CESAREAN SECTION. BABY WAS DELIVERED WITH A SUBGALEAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITY VAC MITY VAC HDB COOPER SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Hospitalization