BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE BRAND

    MDR report key: 7620583 · Received June 20, 2018

    Report

    Report Number
    1825660-2018-00356
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    May 24, 2018
    Report Date
    June 20, 2018
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    K133423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER THREW OUT THE PRODUCT.

    Additional Manufacturer Narrative · 1

    CORRECTING PRODUCT CODE: PREVIOUSLY REPORTED AS SNORE GUARD/LRK. CORRECTED TO LIFE BRAND/OBR AND 501K NUMBER.

    Description of Event or Problem · 1

    CONSUMER STATED HE "FOLLOWED INSTRUCTIONS BUT THE PROCESS DIDN'T WORK WELL. THE GEL GOT STUCK TO THE DENTAL PROTECTOR, IN ONE OF THE TWO INSISTENCE IT TORE IN HALF." CONSUMER SENT PICTURES, HE THREW THE GUARD OUT.

    Description of Event or Problem · 1

    CONSUMER STATED HE "FOLLOWED INSTRUCTIONS BUT THE PROCESS DIDN'T WORK WELL. THE GEL GOT STUCK TO THE DENTAL PROTECTOR, IN ONE OF THE TWO INSISTENCE IT TORE IN HALF." CONSUMER SENT PICTURES, HE THREW THE GUARD OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465875 LIFE BRAND MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD RST ASRD W/TRAY 2CT CRTN BILINGUAL 190240B

    Patients

    Seq Age Sex Outcome Treatment
    1