BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI-VERSITAL KNEE IMMOBILIZER

    MDR report key: 91513 · Received February 15, 1995

    Report

    Report Number
    91513
    Event Type
    Injury
    Date Received
    February 15, 1995
    Date of Event
    October 7, 1994
    Report Date
    October 12, 1994
    Manufacturer
    KIRSCHNER MEDICAL CORP.
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT FITTED WITH KNEE IMMOBILIZER WITH INSTRUCTIONS FOR USE. METAL STAY SLIPPED FROM SLEEVE DOWN TO ANKLE WHEN PT GOT OUT OF BED CAUSING HIM TO FALL. READMISSION TO HOSP. STITCHING EITHER CAME LOOSE OR NEVER THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI-VERSITAL KNEE IMMOBILIZER KNEE IMMOBILIZER ITQ KIRSCHNER MEDICAL CORP. 1201-23 *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization