BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELKYRA SKIN GRID

    MDR report key: 6947380 · Received October 13, 2017

    Report

    Report Number
    2024601-2017-00008
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 11, 2017
    Report Date
    October 13, 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

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF NECROSIS IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING FOR BELKYRA: WARNINGS AND PRECAUTIONS, FOR TOPICAL USE ONLY, DO NOT INJECT THROUGH THE TRANSFERRED GRID MARKINGS, DO NOT USE ON BROKE OR DAMAGED SKIN.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH BELKYRA® A LITTLE OUTSIDE OF THE GRID AREA. THE PATIENT DEVELOPED SKIN NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728123 BELKYRA SKIN GRID MARKER, SKIN FZZ ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BELKRYA¿