BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIAMI NECK COLLAR/BRACE

    MDR report key: 29252 · Received January 5, 1996

    Report

    Report Number
    MW1008061
    Event Type
    Injury
    Date Received
    January 5, 1996
    Date of Event
    July 24, 1995
    Report Date
    December 20, 1995
    Manufacturer
    M-PACT CORP.
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VELCRO STRAPS HAVE COME UNGLUED FROM COLLAR ON MORE THAN 3 OCCASIONS. USED TO BRACE PT'S NECK FOLLOWING CERVICAL FUSIONS. IN RPTR'S OPINION, THE CO HAS NOT RESPONDED QUICKLY OR APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIAMI NECK COLLAR/BRACE NECK COLLAR/BRACE IQK M-PACT CORP. MJ-300

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability