BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCL SPLINT

    MDR report key: 102890 · Received July 3, 1997

    Report

    Report Number
    MW1011617
    Event Type
    Injury
    Date Received
    July 3, 1997
    Date of Event
    June 30, 1997
    Report Date
    July 3, 1997
    Manufacturer
    OCL
    Product Code
    ILH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED REDNESS AND RASH WHERE THE SPLINT HAD CONTACT WITH THE SKIN. THIS WAS EXPERIENCED 72 HOURS AFTER THE APPLICATION OF THE SPLINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCL SPLINT SPLINT ILH OCL UNK 80482

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR