BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPOGEMS

    MDR report key: 10613134 · Received September 30, 2020

    Report

    Report Number
    MW5096992
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 29, 2020
    Manufacturer
    GLOBALMED LOGISTIX, LLC
    Product Code
    MUU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COULD NOT WALK ON THE KNEE; LIPOGEM INJECTION. ONE KNEE NOT IMPACTED. OTHER KNEE HAD EXTREME SWELLING AND PAIN AND IF I WALKED ON IT THE PAIN WAS EXTREME, LIKE COULD PUT NO WEIGHT ON IT EVEN TO WALK TO THE BATHROOM. PAIN WAS AT THE TOP OF THE TIBIA. REST HELPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068998 LIPOGEMS SYSTEM, SUCTION, LIPOPLASTY MUU GLOBALMED LOGISTIX, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other