BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM 10

    MDR report key: 12887561 · Received November 29, 2021

    Report

    Report Number
    1825660-2021-01025
    Event Type
    Malfunction
    Date Received
    November 29, 2021
    Date of Event
    October 31, 2021
    Report Date
    November 29, 2021
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    UDI-DI
    5108090651
    PMA / PMN Number
    K094020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    I SWALLOWED THE NIGHT GUARD I WAS WEARING. WILL IT PASS OK?.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785967 PLACKERS MTH GD GNM 10 MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10 5108090651

    Patients

    Seq Age Sex Outcome Treatment
    1 Female