BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT APPLICABLE

    MDR report key: 2664470 · Received July 17, 2012

    Report

    Report Number
    MW5026223
    Event Type
    Injury
    Date Received
    July 17, 2012
    Date of Event
    March 12, 2012
    Report Date
    July 17, 2012
    Product Code
    LQZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED CUSTOM MADE REPOSITIONING SPLINT TO HELP ALLEVIATE TMD SYMPTOMS. AFTER WEARING THE DEVICE FOR 3 DAYS THE PAIN BECAME SO SEVERE THE PT HAD TO STOP WEARING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT APPLICABLE CUSTOM MADE TMJ REPOSITIONING SPLINT LQZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention