BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUTEAL IMPLANT

    MDR report key: 15562643 · Received October 6, 2022

    Report

    Report Number
    MW5112482
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    January 13, 2021
    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 STATED HE HAD GREAT DIFFICULTLY PLACING THE IMPLANT INTO THE PATIENT. (1 OF 2); SECOND IMPLANT WAS PLACED WITH NO DIFFICULTLY. SINCE HE COULD NOT GET THE IMPLANT INSERTED HE USED ANOTHER COMPANY'S IMPLANTS TO COMPLETE THE SURGERY. BOTH ALPHA AESTHETICS IMPLANTS TO BE RETURNED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2799855 GLUTEAL IMPLANT ELASTOMER, SILICONE BLOCK MIB DSAART, LLC DBA ALPHA AESTHETICS 20-09-018
    2799856 GLUTEAL IMPLANT ELASTOMER, SILICONE BLOCK MIB DSAART, LLC DBA ALPHA AESTHETICS 20-05-022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown