BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHILD SQUISHON 2

    MDR report key: 397218 · Received May 28, 2002

    Report

    Report Number
    MW1025174
    Event Type
    Malfunction
    Date Received
    May 28, 2002
    Report Date
    May 24, 2002
    Manufacturer
    CHILDREN'S MEDICAL VENTURES
    Product Code
    FRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRODUCT LEAKING FROM SHELL. GEL IS YELLOW COLORED WITH AREAS THAT APPEAR LIKE MOLD. SENT 3 BACK TO THE CO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILD SQUISHON 2 GEL FILLED PILLOW FRP CHILDREN'S MEDICAL VENTURES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *