BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 6231449 · Received January 6, 2017

    Report

    Report Number
    3003707320-2017-00003
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    December 1, 2016
    Report Date
    January 6, 2017
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EVALUATED BECAUSE BELLAFILL IS A SINGLE USE DEVICE AND THE SYRINGE WAS DISCARDED BY THE INJECTOR AFTER USE. MANUFACTURING RECORDS WERE REVIEWED FOR LOT USED ON DAY OF THE INJECTION RELATED TO THE REPORTED VASCULAR OCCLUSION LEADING TO NECROSIS (LOT F161019) WITH NO ISSUES NOTED. RETAINED LOT SAMPLES OF LOT F161019 WERE REVIEWED WITH NO ISSUES NOTED. INJECTION PHYSICIAN HAD ALSO RELAYED THAT THE PATIENT HAD BEEN PREVIOUSLY INJECTED WITH BELLAFILL WITHOUT ISSUES: (B)(6) 2016 WITH 2 SYRINGES OF LOT F161020 IN THE NLF AND CHEEKS AND ON (B)(6) 2016 WITH 2 SYRINGES OF LOT F161027 IN THE SAME AREAS. MANUFACTURING RECORDS AND RETAINED LOT SAMPLES WERE ALSO REVIEWED FOR THE LOTS USED IN THE PRIOR INJECTIONS, WITH NO ISSUES NOTED. THE PRODUCT LABELING WARNS INJECTORS "BELLAFILL® MUST NOT BE IMPLANTED INTO BLOOD VESSELS. IMPLANTATION OF BELLAFILL® INTO DERMAL VESSELS MAY CAUSE VASCULAR OCCLUSION, INFARCTION, OR EMBOLIC PHENOMENA." IN ADDITION, PRODUCT LABELING INDICATES "RARE BUT SERIOUS ADVERSE EVENTS ASSOCIATED WITH THE INTRAVASCULAR INJECTION OF SOFT-TISSUE FILLERS IN THE FACE HAVE BEEN REPORTED AND INCLUDE TEMPORARY OR PERMANENT VISION IMPAIRMENT; BLINDNESS; CEREBRAL ISCHEMIA; OR CEREBRAL HEMORRHAGE, LEADING TO STROKE, SKIN NECROSIS, AND DAMAGE TO UNDERLYING FACIAL STRUCTURES. IMMEDIATELY STOP THE INJECTION IF A PATIENT EXHIBITS ANY OF THE FOLLOWING SYMPTOMS, INCLUDING CHANGES IN VISION, SIGNS OF A STROKE, BLANCHING OF THE SKIN, OR UNUSUAL PAIN DURING OR SHORTLY AFTER THE PROCEDURE. PATIENTS SHOULD RECEIVE PROMPT MEDICAL ATTENTION AND POSSIBLY EVALUATION BY AN APPROPRIATE HEALTH CARE PRACTITIONER SPECIALIST SHOULD AN INTRAVASCULAR INJECTION OCCUR."

    Description of Event or Problem · 1

    VASCULAR OCCLUSION OF RIGHT ANGULAR ARTERY LEADING TO NECROSIS IN THE RIGHT NASOLABIAL FOLD (NLF) AFTER BELLAFILL INJECTION IN THE NLFS AND CHEEKS: ON (B)(6) 2016: PATIENT WAS INJECTED WITH 1 SYRINGE OF BELLAFILL IN THE NLF AND CHEEKS. INJECTING PHYSICIAN NOTED NO SWELLING, REDNESS ECCHYMOSIS, BLANCHING, OR PAIN WHEN THE PATIENT LEFT AFTER THE INJECTION. ON (B)(6) 2016: PATIENT NOTICED DISCOLORATION OF THE RIGHT NLF, ON (B)(6) 2016: THE DISCOLORATION BECAME WORSE. PATIENT WENT TO URGENT CARE AND WAS GIVEN MUPIROCIN OINTMENT. ON (B)(6) 2016: PATIENT RETURNED TO INJECTING PHYSICIAN'S OFFICE. ON EXAM THERE WAS ECCHYMOSIS, MILD TENDERNESS AND MINIMAL SWELLING IN THE AREA OF THE RIGHT NLF. IN ADDITION THERE WAS BREAKDOWN OF THE SKIN OF THE RIGHT ALAR CREASE. THERE WAS NO WARMTH, ERYTHEMA OR FLUCTUATION OF THE AREA. THE DOCTOR DIAGNOSED ARTERIAL OCCLUSION OF THE RIGHT ANGULAR ARTERY. THE PATIENT WAS THEN SENT FOR HYPERBARIC OXYGEN TREATMENT STARTING ON (B)(6) 2016 WITH A PLAN FOR AT LEAST 10 TREATMENTS. ON (B)(6) 2016: THE PATIENT EVENT IS REPORTED TO (B)(4) MEDICAL BY THE INJECTING PHYSICIAN. THE PHYSICIAN STATES THAT THE BREAKDOWN OF THE SKIN IS NOW DRYER AFTER 3 TREATMENTS OF HYPERBARIC OXYGEN. SEVEN MORE TREATMENTS ARE PLANNED, TWO A DAY. THE PATIENT WAS ALSO STARTED ON ASPIRIN. ON (B)(6) 2017: THE INJECTING PHYSICIAN RELAYS SHE SAW THE PATIENT ON (B)(6) 2016 AFTER SHE HAD ALL 10 HYPERBARIC OXYGEN TREATMENTS. THE AREA OF SKIN BREAKDOWN WAS NOW GONE, ALL AREAS OF THE SKIN WERE NORMAL PINK COLOR, AND THERE WAS A HEALING ESCHAR ON THE RIGHT NLF. PER THE PHYSICIAN, IT WAS A MARKED IMPROVEMENT. PATIENT HAS RETURN VISIT SCHEDULED IN TWO WEEKS FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14291 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F161019

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention