BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRADLE BOOT

    MDR report key: 1244343 · Received November 25, 2008

    Report

    Report Number
    1041130-2008-00004
    Event Type
    Other
    Date Received
    November 25, 2008
    Report Date
    November 24, 2008
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEM, INC.
    Product Code
    CCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS USED THIS PRODUCT FOR YEARS, AND THIS IS THE FIRST AND ONLY OCCURRENCE OF THIS NATURE. CO HAS HAD THIS PRODUCT ON THE MARKET FOR MORE THAN 20 YEARS, AND THIS IS THE FIRST REPORT OF THIS NATURE. THE PRODUCT WAS NOT RETURNED, AND THUS AN INVESTIGATION COULD NOT BE PERFORMED. IN OUR INVESTIGATION WITH THE FOAM SUPPLIER, IT IS SPECULATED THAT AN OCCURRENCE OF THIS NATURE IS POSSIBLE IF THERE IS A PROBLEM IN THE CHEMICAL MIX AND POUR, THIS IS A CONTINUOUS MIX AND POUR PROCESS. IT COULD OCCUR IN A SMALL ISOLATED PORTION OF THE POUR, AND THUS NOT BE APPARENT WHEN THE LARGE BUN OF FOAM IS RECEIVED FOR FURTHER FABRICATION INTO INDIVIDUAL PRODUCTS. THE PATIENTS THAT USED THE CRADLE BOOTS AT THIS TIME ARE ALL OK WITHOUT FURTHER COMPLICATION.

    Description of Event or Problem · 1

    RECEIVED A CALL THAT FOAM FOR THE CRADLE BOOT, CATALOG # 50644-315 WAS HARD AND ROUGH TO THE TOUCH. CAUSED SORE AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRADLE BOOT FOOT POSITIONER CCX SPAN-AMERICA MEDICAL SYSTEM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1