BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL

    MDR report key: 2341654 · Received November 13, 2011

    Report

    Report Number
    MW5023110
    Event Type
    Injury
    Date Received
    November 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    November 13, 2011
    Manufacturer
    SUNEVA
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ARTEFIL, LOT # F111003 SUNEVA MEDICAL INC. EXP 08/2012. PRODUCT INJECTED IN NASOLABIAL FOLDS AND CHEEKS .8CC. POST INSPECTION PAIN (BURNING), LUMPS, SWELLING, REDNESS. PERSISTS 5 MONTHS LATER. HAVE TRIED ANTIBIOTICS, STEROID INJECTIONS AND NO RELIEF. UNABLE TO MAKE CONTACT WITH VENDOR FOR ASSISTANCE AND/OR GUIDANCE. PROVIDER IS OFFERING NO SUGGESTIONS AS TO HOW TO HELP ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTEFILL ARTEFILL LMH SUNEVA F111003

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention