BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCL 22" LONG

    MDR report key: 187720 · Received September 15, 1998

    Report

    Report Number
    1928508-1998-00001
    Event Type
    Other
    Date Received
    September 15, 1998
    Report Date
    September 11, 1998
    Manufacturer
    M-PACT WORLDWIDE MANAGEMENT
    Product Code
    FYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN CLAIMS THAT USE OF "SUGAR TONG SPLINT" CAUSED SEVERE CONTACT DERMATITIS ON HIS PATIENT. THE DERMATITIS WAS SO SEVERE THAT IT WAS MORE LIKE A BURN. PHYSICIAN BELIEVES THE INNER CORE MATERIAL IS THE PROBLEM, NOT THE FOAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCL 22" LONG SUGAR TONG SPLINT FYH M-PACT WORLDWIDE MANAGEMENT NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other