BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM 10

    MDR report key: 10891117 · Received November 24, 2020

    Report

    Report Number
    1825660-2020-00850
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 31, 2020
    Report Date
    November 23, 2020
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    UDI-DI
    00651080906517
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED: MY MOUTH BROKE OUT AFTER USING THE GRIND NO MORE DISPOSABLE NIGHT GUARD, AN ALLERGIC REACTION. I SEE THAT THEY ARE BPA AND LATEX FREE, BUT WHAT MATERIAL ARE THEY MADE OF? NITRILE? I'M ASKING DO I KNOW WHAT MATERIALS TO STAY AWAY FROM DUE TO THE REACTION I HAD. PRODUCT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354598 PLACKERS MTH GD GNM 10 MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10 CA 00651080906517

    Patients

    Seq Age Sex Outcome Treatment
    1