BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCK A-BYE LABOR BIRTHBALL

    MDR report key: 489913 · Received October 20, 2003

    Report

    Report Number
    489913
    Event Type
    Malfunction
    Date Received
    October 20, 2003
    Date of Event
    June 1, 2003
    Report Date
    June 1, 2003
    Manufacturer
    SISSEL, INC
    Product Code
    MPF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE PT WAS SITTING ON THE BIRTHING BALL, THE BALL RIPPED OPEN. THE PT FELL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCK A-BYE LABOR BIRTHBALL BIRTHING BALL MPF SISSEL, INC 65 CM 26 IN *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other