BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVARE PLUS LED INFARED DEVICE

    MDR report key: 11885363 · Received May 25, 2021

    Report

    Report Number
    MW5101549
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    November 12, 2020
    Report Date
    May 24, 2021
    Manufacturer
    ELEVARE SKIN,WOODLAND HILLS, CA / OMM IMPORTS, INC. D/B/A ZERO GRAVITY
    Product Code
    OHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED ELEVARE PLUS LED INFRARED DEVICE IN (B)(6) 2018 FOR (B)(6) DEVICE IS AN FDA CLASS II CLEARED DEVICE AND HAS A LIFETIME WARRANTY. PRODUCT WAS USED SPORADICALLY IN THE NEXT 2 YEARS THEN COMPLETELY STOPPED WORKING ( WOULD NOT TURN ON, WOULD NOT TAKE A CHARGE) IN (B)(6) 2020. I WOULD EXPECT A PRODUCT AT THIS PRICE POINT TO BE MANUFACTURED OF HIGH QUALITY, DURABLE COMPONENTS AND NOT TO STOP WORKING AT 2 YEARS OF MINIMAL USE. I HIGHLY QUESTION THE MANUFACTURING QUALITY OF THIS PRODUCT. PRODUCT WAS RETURNED TO THE COMPANY, DEEMED DEFECTIVE AND REPLACED UNDER WARRANTY, BUT WAS CHARGED (B)(6) FOR SHIPPING AND HANDLING WHICH ALSO SEEMED UNREASONABLE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772849 ELEVARE PLUS LED INFARED DEVICE LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS ELEVARE SKIN,WOODLAND HILLS, CA / OMM IMPORTS, INC. D/B/A ZERO GRAVITY WARRANTY ID ELV-2149723

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR