BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN VISTA

    MDR report key: 11663865 · Received April 13, 2021

    Report

    Report Number
    MW5100751
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    April 9, 2021
    Report Date
    April 9, 2021
    Manufacturer
    DJO GLOBAL / DJO, LLC
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NECKBRACE DEFECTIVE NECKPAIN; GOT DEFECTIVE NECKBRACE, NECKPAIN BECAME WORSE. ATTEMPTED CALLING PROVIDER WAS HUNG UP ON 3 TIMES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555348 ASPEN VISTA ORTHOSIS, CERVICAL IQK DJO GLOBAL / DJO, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other