BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVOPLASTY

    MDR report key: 15606903 · Received October 13, 2022

    Report

    Report Number
    MW5112647
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    October 10, 2022
    Report Date
    October 12, 2022
    Manufacturer
    ZELEGENT, INC.
    Product Code
    LRK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD "ELEVOPLAST" FRIDAY 10/7 AND IT DID NOT GO AS PLANNED. SALES REP WAS PRESENT, BUT PRODUCT HAS FAILED TO BE ACCEPTED DESPITE CLINICAL TRIALS SUGGESTING OTHERWISE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242371 ELEVOPLASTY DEVICE, ANTI-SNORING LRK ZELEGENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male ALPRAZOLAM| CETIRIZINE| DULOXETINE| LAMOTRIGINE| LOSARTAN