BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYBELLA SKIN GRID

    MDR report key: 6938536 · Received October 10, 2017

    Report

    Report Number
    2024601-2017-00007
    Event Type
    Injury
    Date Received
    October 10, 2017
    Report Date
    October 10, 2017
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    FZZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF NERVE DAMAGE, DENT, HANGING WRINKLY SKIN, DISTRESSED, SKIN GOT INFLAMED AND DISFIGUREMENT ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING FOR THE REPORTED EVENTS: WARNINGS AND PRECAUTIONS: FOR TOPICAL USE ONLY. DO NO INJECT THROUGH THE TRANSFERRED GRID MARKINGS. DO NOT USE ON BROKE OR DAMAGED SKIN.

    Description of Event or Problem · 1

    PATIENT REPORTED BEING INJECTED WITH KYBELLA BY A DOCTOR AND HAD BEEN LEFT WITH "NERVE DAMAGE WHICH IS NOT RESOLVING AFTER 6 WEEKS" AND "A DENT" ON THEIR NECK WITH "TWO BITS OF HANGING WRINKLY SKIN" THAT "WILL NEED COSMETIC SURGERY CORRECTION." PATIENT WAS DISTRESSED AND CLAIMED THAT THE PRODUCT HAS LEFT THE PATIENT WITH "DISFIGUREMENT." THE PATIENT NOTED THEY COULD NOT SMILE AND THAT THEIR "FACE SKIN GOT INFLAMED" AS WELL AS THEIR LIPS. PATIENT HAD GONE TO THE EMERGENCY ROOM WHICH INFORMED THE PATIENT OF HAVING NERVE DAMAGE. PATIENT NOTES THE SHAPE OF THEIR FACE IS DIFFERENT THAN BEFORE AND IS NOT BETTER. PATIENT STILL HAS ALL SYMPTOMS AND SAGGING SKIN. IT IS UNKNOWN IF THE SKIN GRID WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714138 KYBELLA SKIN GRID MARKER, SKIN FZZ ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention