BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIAMI J COLLAR

    MDR report key: 37560 · Received July 12, 1996

    Report

    Report Number
    37560
    Event Type
    Injury
    Date Received
    July 12, 1996
    Date of Event
    February 28, 1996
    Report Date
    March 6, 1996
    Manufacturer
    JERMOME MEDICAL
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VELCRO STRAPS ON COLLAR CAME LOOSE X 2 FOR PT. PT DEVELOPED INCREASED PAIN. COLLAR J REMOVED AND ANOTHER COLLAR APPLIED. TWO COLLARS WERE TRIED. BOTH VELCRO STRAPS OPENED SPONTANEOUSLY. LOT TO BE RECALLED BY MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIAMI J COLLAR CERVICAL COLLAR IQK JERMOME MEDICAL MJP-300 H IOE-18254

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention