BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENDY BUMPER

    MDR report key: 246009 · Received October 22, 1999

    Report

    Report Number
    MW1017399
    Event Type
    Injury
    Date Received
    October 22, 1999
    Date of Event
    July 1, 1999
    Report Date
    October 22, 1999
    Manufacturer
    CHILDREN'S MEDICAL VENTURES, INC.
    Product Code
    FRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEAD ROD (WHICH IS COVERED BY PLASTIC AND ENCASED IN A NUMBER OF INCHES THICK FOAM WHICH IS THEN COVERED BY PLASTIC AND ALSO FLANNEL COVERING ON OUTSIDE) BROKE OVER COURSE OF THREE MONTHS (3 DIFFERENT ONES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENDY BUMPER AID IN POSITIONING NEONATE FRP CHILDREN'S MEDICAL VENTURES, INC. 92065 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention