BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA-SPLINT SYNTH RL 4"X15FT

    MDR report key: 488793 · Received October 10, 2003

    Report

    Report Number
    1818910-2003-00668
    Event Type
    Malfunction
    Date Received
    October 10, 2003
    Date of Event
    September 10, 2003
    Report Date
    September 10, 2003
    Manufacturer
    DEPUY-NORTH BRUNSWICK CASTING PRODUCTS DIV.
    Product Code
    FYH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVERAL PEOPLE GOT A LONGUETTE DELTA SPLINT ON THE LOWER LEG IN U-FORM. THEY ALL HAD MACERATIONS AT THEIR HEELS AND BUBBLES ON THE SKIN OR EVEN OPEN WOUNDS. THE PTS WERE TREATED WITH PRODUCTS FROM ANOTHER SUPPLIER BEFORE, WITH THESE THEY HAD NO PROBLEMS. IT WAS REPORTED THAT THE DELTA SPLIT IS VERY SLOW DRYING ALTHOUGH IT WAS EXPRESSED IN A TOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA-SPLINT SYNTH RL 4"X15FT CASTING FYH DEPUY-NORTH BRUNSWICK CASTING PRODUCTS DIV. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA