BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASCIABLASTER

    MDR report key: 8915554 · Received August 20, 2019

    Report

    Report Number
    MW5089211
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    February 11, 2018
    Report Date
    August 17, 2019
    Manufacturer
    ADB INTERESTS, LLC
    Product Code
    LYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED THE FASCIABLASTER AND MINIBLASTER ON MY LEG AND FACE AND NECK AS DIRECTED. NERVE ISSUES STARTED TO OCCUR. COULDN'T SWALLOW PROPERLY FOR MONTHS, LEFT LEG NERVE ISSUES NOTED BY NEUROLOGIST. WASN'T ABLE TO MOVE MY LEFT TOES. HAVE LUMPS UNDER SKIN THAT WERE NOT THERE BEFORE USING THE PRODUCT. INCREASED MENSTRUAL BLEEDING DURING USE OF DEVICES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707267 FASCIABLASTER MASSAGER, THERAPEUTIC, MANUAL LYG ADB INTERESTS, LLC 89-IOS AT 21 CFR 8905350
    707268 MINI BLASTER MASSAGER, THERAPEUTIC, MANUAL LYG ADB INTERESTS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability