BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM

    MDR report key: 11007086 · Received December 15, 2020

    Report

    Report Number
    1825660-2020-00864
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 14, 2020
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    UDI-DI
    51080651516
    PMA / PMN Number
    K094020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED: "HI, I WAS JUST WRITING AS I SPENT THIS MORNING IN THE EMERGENCY AS I CHOCKED AND SWALLOWED ONE OF YOUR PRODUCTS. THIS IS SO DANGEROUS! NOW I HAVE NO IDEA HOW THIS WILL COME OUT OF ME AND THAT IS BEYOND MESSED UP. PLEASE REVIEW YOUR PRODUCTS I WAS IN SO MUCH PAIN AND SCARED. I CAN SHOW MEDICAL RECORDS TO SHOW THIS IS A REAL COMPLAINT. PLEASE MAKE SAFIER HARDER LARGER VERSION THAT IS SAFE PLEASE." RESPONDED TO CONSUMER VIA (B)(6). NO FURTHER RESPONSE WAS RECEIVED FROM CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478909 PLACKERS MTH GD GNM MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10 51080651516

    Patients

    Seq Age Sex Outcome Treatment
    1