BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLACKERS MTH GD GNM 10CT

    MDR report key: 7915478 · Received September 27, 2018

    Report

    Report Number
    1825660-2018-00421
    Event Type
    Injury
    Date Received
    September 27, 2018
    Date of Event
    September 14, 2018
    Report Date
    September 27, 2018
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED IN ASKING IF THERE WAS LATEX IN THE PRODUCT. "I AM ALLERGIC TO IF LATEX AND HAD A REACTION TO IT SO I AM JUST WONDERING IF THAT'S WHAT IT IS!!"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756200 PLACKERS MTH GD GNM 10CT MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10CT

    Patients

    Seq Age Sex Outcome Treatment
    1