BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUTEAL IMPLANT STYLE 2 SIZE 3

    MDR report key: 15562300 · Received October 6, 2022

    Report

    Report Number
    MW5112479
    Event Type
    Injury
    Date Received
    October 6, 2022
    Report Date
    October 4, 2022
    Manufacturer
    DSAART, LLC., DBA ALPHA AESTHETICS
    Product Code
    MIB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DR CALLED TO REPORT HE HAD TO REMOVE AN IMPLANT FROM A PATIENT THAT WAS IN 3 PIECES. WANTED TO KNOW IF THIS HAS EVER HAPPENED BEFORE AND WHAT WAS OUR CURRENT MARKET SHARE. HE WANTED TO KNOW THIS SO HE WOULD KNOW WHO TO BUY IMPLANTS FROM NEXT TIME. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2799851 GLUTEAL IMPLANT STYLE 2 SIZE 3 ELASTOMER, SILICONE BLOCK MIB DSAART, LLC., DBA ALPHA AESTHETICS 07-06-025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention