BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS STOP GRINDING

    MDR report key: 4241375 · Received November 10, 2014

    Report

    Report Number
    1825660-2014-00944
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 22, 2014
    Manufacturer
    RANIR, LLC
    Product Code
    OBR
    PMA / PMN Number
    K091175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OF THE GUARDS BROKE. ABLE TO USE THE 1ST FOR ABOUT 3 WEEKS, THEN THE 2ND ON BROKE OFF AFTER 1 NIGHT. THIS IS REPORTED AS A POSSIBLE MALFUNCTION.

    Description of Event or Problem · 1

    ONE OF THE GUARDS BROKE. ABLE TO USE THE 1ST FOR ABOUT 3 WEEKS, THEN THE 2ND ON BROKE OFF AFTER 1 NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723285 PLACKERS STOP GRINDING NITE GUARD OBR RANIR, LLC NO BOIL NITE PROTECTOR

    Patients

    Seq Age Sex Outcome Treatment
    1