BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASCIABLASTER

    MDR report key: 11412507 · Received March 3, 2021

    Report

    Report Number
    MW5099775
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    January 1, 2021
    Report Date
    March 1, 2021
    Manufacturer
    ASHLEY BLACK/ ADB INTERESTS, LLC
    Product Code
    LYG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS FASCIABLASTER DEVICE SPONTANEOUSLY FRACTURED INTO MANY PIECES WITH SHARP SHARDS OF PLASTIC. I PRIMARILY USED IT IN THE SHOWER. IT WAS NOT IN USE WHEN IT FRACTURED APART. THIS IS THE SECOND FASCIABLASTER I'VE HAD THAT DID THIS. THE FIRST TIME I REQUESTED A REPLACEMENT FROM THE COMPANY. THIS TIME I AM REACHING OUT TO YOU. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305109 FASCIABLASTER MASSAGER, THERAPEUTIC, MANUAL LYG ASHLEY BLACK/ ADB INTERESTS, LLC US PAT D735,818 2.0 121016
    305110 FASCIABLASTER MASSAGER, THERAPEUTIC, MANUAL LYG ASHLEY BLACK/ ADB INTERESTS, LLC US PAT D735,818

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other