BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYBELLA SKIN GRID

    MDR report key: 7116811 · Received December 14, 2017

    Report

    Report Number
    2024601-2017-00013
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 14, 2017
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    FZZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF ¿NERVE WAS HIT AND NOW SHE HAS A CROOKED SMILE¿ IS A PHYSIOLOGICAL/PROCEDURAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING: 2 DOSAGE AND ADMINISTRATION. 2.3 INJECTION TECHNIQUE. THE SAFE AND EFFECTIVE USE OF KYBELLA DEPENDS ON THE USE OF THE CORRECT NUMBER AND LOCATIONS FOR INJECTIONS, PROPER NEEDLE PLACEMENT, AND ADMINISTRATION TECHNIQUES. HEALTH CARE PROFESSIONALS ADMINISTERING KYBELLA MUST UNDERSTAND THE RELEVANT SUBMENTAL ANATOMY AND ASSOCIATED NEUROMUSCULAR STRUCTURES IN THE AREA INVOLVED AND ANY ALTERATIONS TO THE ANATOMY DUE TO PRIOR SURGICAL OR AESTHETIC PROCEDURES [SEE WARNINGS AND PRECAUTIONS (5)]. AVOID INJECTIONS NEAR THE AREA OF THE MARGINAL MANDIBULAR NERVE [SEE WARNINGS AND PRECAUTIONS (5.1)] NEEDLE PLACEMENT WITH RESPECT TO THE MANDIBLE IS VERY IMPORTANT AS IT REDUCES THE POTENTIAL FOR INJURY TO THE MARGINAL MANDIBULAR NERVE, A MOTOR BRANCH OF THE FACIAL NERVE. INJURY TO THE NERVE PRESENTS AS AN ASYMMETRICAL SMILE DUE TO PARESIS OF LIP DEPRESSOR MUSCLES [SEE WARNINGS AND PRECAUTIONS (5.1)]. TO AVOID INJURY TO THE MARGINAL MANDIBULAR NERVE: DO NOT INJECT ABOVE THE INFERIOR BORDER OF THE MANDIBLE. DO NOT INJECT WITHIN A REGION DEFINED BY A 1-1.5 CM LINE BELOW THE INFERIOR BORDER (FROM THE ANGLE OF THE MANDIBLE TO THE MENTUM). INJECT KYBELLA ONLY WITHIN THE TARGET SUBMENTAL FAT TREATMENT AREA. AVOID INJECTION INTO THE PLATYSMA. PRIOR TO EACH TREATMENT SESSION, PALPATE THE SUBMENTAL AREA TO ENSURE SUFFICIENT SUBMENTAL FAT AND TO IDENTIFY SUBCUTANEOUS FAT BETWEEN THE DERMIS AND PLATYSMA (PRE-PLATYSMAL FAT) WITHIN THE TARGET TREATMENT AREA (FIGURE 2). THE NUMBER OF INJECTIONS AND THE NUMBER OF TREATMENTS SHOULD BE TAILORED TO THE INDIVIDUAL PATIENT¿S SUBMENTAL FAT DISTRIBUTION AND TREATMENT GOALS. INJECTING INTO THE TREATMENT AREA. USE OF ICE/COLD PACKS, TOPICAL AND/OR INJECTABLE LOCAL ANESTHESIA (E.G., LIDOCAINE) MAY ENHANCE PATIENT COMFORT. OUTLINE THE PLANNED TREATMENT AREA WITH A SURGICAL PEN AND APPLY A 1 CM INJECTION GRID TO MARK THE INJECTION SITES (FIGURES 2 AND 3). DO NOT INJECT KYBELLA OUTSIDE THE DEFINED PARAMETERS [SEE WARNINGS AND PRECAUTIONS (5.1, 5.4)]. USING A LARGE BORE NEEDLE, DRAW 1 ML OF KYBELLA INTO A STERILE 1 ML SYRINGE AND EXPEL ANY AIR BUBBLES IN THE SYRINGE BARREL. HAVE THE PATIENT TENSE THE PLATYSMA. PINCH THE SUBMENTAL FAT AND, USING A 30 GAUGE (OR SMALLER) 0.5-INCH NEEDLE, INJECT 0.2 ML OF KYBELLA INTO THE PRE-PLATYSMAL FAT (SEE FIGURE 2) NEXT TO EACH OF THE MARKED INJECTION SITES BY ADVANCING THE NEEDLE PERPENDICULAR TO THE SKIN. INJECTIONS THAT ARE TOO SUPERFICIAL (INTO THE DERMIS) MAY RESULT IN SKIN ULCERATION. DO NOT WITHDRAW THE NEEDLE FROM THE SUBCUTANEOUS FAT DURING INJECTION AS THIS COULD INCREASE THE RISK OF INTRADERMAL EXPOSURE AND POTENTIAL SKIN ULCERATION. AVOID INJECTING INTO THE POST-PLATYSMAL FAT BY INJECTING KYBELLA INTO FAT TISSUE AT THE DEPTH OF APPROXIMATELY MID-WAY INTO THE SUBCUTANEOUS FAT LAYER (FIGURE 2). IF AT ANY TIME RESISTANCE IS MET AS THE NEEDLE IS INSERTED, INDICATING THE POSSIBILITY OF CONTACT WITH FASCIAL OR NONFAT TISSUE, THE NEEDLE MUST BE WITHDRAWN TO AN APPROPRIATE DEPTH BEFORE THE INJECTION IS ADMINISTERED. AVOID INJECTING INTO OTHER TISSUES SUCH AS THE MUSCLE, SALIVARY GLANDS AND LYMPH NODES. UPON NEEDLE WITHDRAWAL, PRESSURE MAY BE APPLIED TO EACH INJECTION SITE AS NECESSARY TO MINIMIZE BLEEDING; AN ADHESIVE DRESSING MAY BE APPLIED. WARNINGS AND PRECAUTIONS: MARGINAL MANDIBULAR NERVE INJURY. CASES OF MARGINAL MANDIBULAR NERVE INJURY, MANIFESTED AS AN ASYMMETRIC SMILE OR FACIAL MUSCLE WEAKNESS (PARESIS), WERE REPORTED DURING CLINICAL TRIALS. TO AVOID THE POTENTIAL FOR NERVE INJURY, KYBELLA SHOULD NOT BE INJECTED INTO OR IN CLOSE PROXIMITY TO THE MARGINAL MANDIBULAR BRANCH OF THE FACIAL NERVE. ALL MARGINAL MANDIBULAR NERVE INJURIES REPORTED FROM THE TRIALS RESOLVED SPONTANEOUSLY (RANGE 1-298 DAYS, MEDIAN 44 DAYS). DYSPHAGIA: DIFFICULTY SWALLOWING (DYSPHAGIA) OCCURRED IN CLINICAL TRIALS IN THE SETTING OF ADMINISTRATION SITE REACTIONS, E.G., PAIN, SWELLING, AND INDURATION OF THE SUBMENTAL AREA. CASES OF DYSPHAGIA SPONTANEOUSLY RESOLVED (RANGE 1-81 DAYS, MEDIAN 3 DAYS). SUBJECTS WITH CURRENT OR PRIOR HISTORY OF DYSPHAGIA WERE EXCLUDED FROM CLINICAL TRIALS. AVOID USE OF KYBELLA IN THESE PATIENTS AS CURRENT OR PRIOR HISTORY OF DYSPHAGIA MAY EXACERBATE THE CONDITION. RISK OF INJECTING IN PROXIMITY TO VULNERABLE ANATOMIC STRUCTURES: TO AVOID POTENTIAL TISSUE DAMAGE, KYBELLA SHOULD NOT BE INJECTED INTO OR IN CLOSE PROXIMITY (1-1.5 CM) TO SALIVARY GLANDS, LYMPH NODES AND MUSCLES. ADVERSE REACTIONS: TABLE 1. ADVERSE REACTIONS IN THE POOLED TRIALS 1 AND 2A. THE MOST COMMONLY REPORTED ADVERSE REACTIONS INCLUDE: EDEMA/SWELLING, HEMATOMA/BRUISING, PAIN, NUMBNESS, ERYTHEMA, INDURATION, PARESTHESIA, NODULE, PRURITUS, SKIN TIGHTNESS, SITE WARMTH, NERVE INJURY, HEADACHE, OROPHARYNGEAL PAIN, HYPERTENSION, NAUSEA, AND DYSPHAGIA. OTHER ADVERSE REACTIONS ASSOCIATED WITH THE USE OF KYBELLA INCLUDE: INJECTION SITE HEMORRHAGE, INJECTION SITE DISCOLORATION, PRE-SYNCOPE/SYNCOPE, LYMPHADENOPATHY, INJECTION SITE URTICARIA AND NECK PAIN.

    Description of Event or Problem · 1

    PATIENT REPORTED THE EVENT OF AFTER INJECTION FOR THE TREATMENT OF SUBMENTAL FAT WITH KYBELLA® THE PATIENT STATED THAT THEIR NERVE WAS HIT AND NOW THEY HAVE A CROOKED SMILE. THE KYBELLA® SKIN GRID WAS USED. NO TREATMENT HAS BEEN PROVIDED. THE PATIENT ALSO STATED THAT SHE RECEIVED KYBELLA® ONCE ABOUT A YEAR AGO WITH NO ISSUES. NO INDICATION PROVIDED IF THERE WAS RESOLUTION FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895689 KYBELLA SKIN GRID MARKER, SKIN FZZ ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention