BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO GLASS

    MDR report key: 91591 · Received February 15, 1995

    Report

    Report Number
    91591
    Event Type
    Malfunction
    Date Received
    February 15, 1995
    Date of Event
    October 28, 1994
    Report Date
    November 18, 1994
    Manufacturer
    PARKER MEDICAL ASSOCIATES
    Product Code
    FYH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORHTO SPLINT APPLIED FOR WRIST FRACTURE. PT SUFFERED SKIN TRAUMA, WAS SEEN AT ANOTHER EMERGENCY ROOM, SKIN BREAKDOWN WAS OBSERVED ON PT'S ARM BY PHYSICIAN CHECKING UNDER SPLINT. SPLINT WAS ON FOR ONLY 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO GLASS FIBERGLASS SPLINT SYSTEM FYH PARKER MEDICAL ASSOCIATES * G43108 POSSIBLE LOT#

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other