BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCARE ONE-PIECE CERVICAL COLLAR

    MDR report key: 8623742 · Received May 17, 2019

    Report

    Report Number
    MW5086721
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 14, 2019
    Report Date
    May 16, 2019
    Manufacturer
    DJO, LLC
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON MULTIPLE OCCASIONS, THE PRODUCT (PROCARE BLACK ONE-PIECE CERVICAL COLLAR - 79-83131) BROKE WHILE IT WAS BEING SIZED / APPLIED TO THE PT WHILE BEING USED / APPLIED IN ACCORDANCE WITH MFR'S INSTRUCTIONS. GENERALLY, THE BREAK OCCURS IN THE AREA WHERE THE COLLAR FITS UNDER THE CHIN (GREY PLASTIC IN PICTURES). AT ONE TIME, A SMALL PIECE OF HARD PLASTIC BROKE OFF. FLEW THROUGH THE AIR, AND JUST NARROWLY MISSED HITTING SOMEONE IN THE FACE. PEOPLE APPLYING THIS COLLAR SEEM TO EXPERIENCE A >50% FAILURE / BREAKAGE RATE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411844 PROCARE ONE-PIECE CERVICAL COLLAR ORTHOSIS, CERVICAL IQK DJO, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other