BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 6836897 · Received August 31, 2017

    Report

    Report Number
    3003707320-2017-00011
    Event Type
    Injury
    Date Received
    August 31, 2017
    Date of Event
    June 13, 2017
    Report Date
    August 31, 2017
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ITSELF 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 ISSUE (LOT F171031) WITH NO ISSUES NOTED. RETAINED LOT SAMPLES OF LOT F171031 WERE REVIEWED WITH NO ISSUES NOTED. THE PATIENT WAS INJECTED OFF-LABEL IN THE LIPS BY THE INJECTING PHYSICIAN, WHICH IS CONTRAINDICATED FOR BELLAFILL AND IS DOCUMENTED IN THE IN THE BELLAFILL IFU LABELING. THE INJECTOR IS AWARE OF BELLAFILL INDICATIONS FOR USE. 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 AFTER CONTRAINDICATED BELLAFILL INJECTION IN THE LIP ON (B)(6) 2017 REQUIRING MEDICAL INTERVENTION. INJECTING DOCTOR BELIEVES THE OCCLUSION WAS LIKELY CAUSED BY THE INJECTION OBSTRUCTING A LITTLE TRIBUTARY THAT RUNS THRU THE LIP.MEDICAL INTEVENTION INCLUDED NITROBIT, HYALENEX, ASPIRIN, AND HYPERBARIC CHAMBER TREATMENT. ON (B)(6) 2017, THE PATIENT NOTIFIED THE INJECTOR THAT SHE WAS PREGNANT AND, AFTER CONSULTATION WITH AN OB-GYN, THE TREATMENT WAS MODIFIED TO 5MG PREDNISONE AND "SWISH AND SWALLOW" NUMBING MEDS FOR PAIN. THE INJECTOR STATES THAT, OVER A WEEK'S TIME, VESICLES FORMED, THEN HEALED, AND A SCAB ON THE OUTSIDE COMPLETELY HEALED WITH A LIGHT BRUISE. AS OF (B)(6) 2017, THE PATIENT WAS COMPLETELY HEALED. THE EVENT REPORTED TO SUNEVA MEDICAL ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613767 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F171031

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention