BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELKYRA SKIN GRID

    MDR report key: 6949513 · Received October 13, 2017

    Report

    Report Number
    2024601-2017-00009
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 1, 2017
    Report Date
    November 6, 2017
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    FZZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS NECROTIC TISSUE, ABSCESS AND DIMPLING/INDURATION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    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 EVENTS OF SWELLING, REDNESS, PAIN, MALAISE, UNABLE TO SLEEP AND (B)(6) INFECTION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING FOR BELKYRA¿: WARNINGS AND PRECAUTIONS. FOR TOPICAL USE ONLY. DO NOT INJECT THROUGH THE TRANSFERRED GRID MARKINGS. DO NO USE ON BROKEN OR DAMAGED SKIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: INJECTION AREA WAS PREPPED WITH CHLORHEXIDINE 0.05% ANTISEPTIC RESOLUTION PRIOR TO INJECTION. PATIENT WAS ADVISED TO USE COLD COMPRESS FOR SHORT PERIODS AFTER THE INJECTION AND TO KEEP THE AREA CLEAN AND HYDRATED. PATIENT WAS FREE FROM ANY INFECTION/INFLAMMATION PRIOR TO INJECTION. PATIENT HAD DEVELOPED A DELAYED ABSCESS WITHIN THE NECROTIC TISSUE OF THE SUBMENTAL FAT WHICH REQUIRED ANTIBIOTICS THERAPY AND ASPIRATION OF SIGNIFICANT SWELLING. PATIENT HAS HAD MULTIPLE REVIEWS SINCE TREATMENT WAS PROVIDED AND ONGOING SUPPORT. PATIENT STILL HAS A SMALL SUBMENTAL ABSCESS AND RELATED DIMPLING/INDURATION OF THE SKIN. SYMPTOMS ARE ONGOING AND PATIENT CONTINUES TO TAKE ORAL ANTIBIOTICS. PATIENT MAY BE LEFT WITH PERMANENT SCARRING IN THE AREA AND AN UNDESIRABLE COSMETIC OUTCOME.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH BELKYRA USING THE SKIN GRID TO THE SUBMENTAL FAT REGION. PATIENT DEVELOPED SWELLING AFTER THE INJECTION AND 18 DAYS LATER HAD SWELLING BEYOND NORMAL EXPECTATIONS WITH REDNESS AND PAIN. THE PATIENT HAD MALAISE AND WAS UNABLE TO SLEEP AFTER THE INJECTION. THE SWOLLEN AREA WAS ASPIRATED AND THE PATIENT WAS COMMENCED ON CEPHALEXIN. THREE DAYS LATER, THE PATIENT HAD ANOTHER ASPIRATION AND COMMENCED ON DICLOXACILLIN. AFTER THE BELKYRA HAD BEEN DRAINED, THE HEALTHCARE PROFESSIONAL NOTICED LYMPHOCYTES IN THE AREA WHICH INDICATED AN INFECTION. A CULTURE OF THE ASPIRATION SHOWED HEAVY GROWTH OF (B)(6). PATIENT SYMPTOMS ARE IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727396 BELKYRA SKIN GRID MARKER, SKIN FZZ ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention| S