BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITY VAC

    MDR report key: 1003978 · Received February 25, 2008

    Report

    Report Number
    1216677-2008-00006
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 25, 2008
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PUMP WAS RETURNED. THE PUMP WAS FOUND TO HAVE THE TUBING REMOVER AND VACUUM RELEASE TRIGGER BROKEN OFF. NO BROKEN PIECES WERE FOUND INSIDE THE SHIPPING CONTAINER. THE APPEARANCE IS THE TRIGGER WAS BROKEN PRIOR TO USE IN THIS EVENT CAUSING THE VACUUM TO REMAIN IN PLACE UNTIL THE TUBING WAS REMOVED FROM THE PUMP. THE OPERATIONAL GUIDELINES FOR THE PUMP CARRIES A RECOMMENDATION TO CHECK THE EQUIPMENT PRIOR TO EACH USE. A HEMATOMA IS A POSSIBLE FETAL INJURY SUSTAINABLE DURING VACUUM ASSISTED DELIVERY AS LISTED ON THE OPERATIONAL GUIDELINES ON THE EXTRACTOR CUP.

    Description of Event or Problem · 1

    DURING A VACUUM ASSISTED DELIVERY, THE VAD DEVICE WOULD NOT RELEASE VACUUM. THE PT DEVELOPED A HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITY VAC VACUUM ASSIST DELIVERY PUMP HDB COOPERSURGICAL, INC. 10022 53572

    Patients

    Seq Age Sex Outcome Treatment
    1 YR