BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 7072320 · Received November 30, 2017

    Report

    Report Number
    3003707320-2017-00013
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    October 30, 2017
    Report Date
    November 30, 2017
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED VASCULAR OCCLUSION LEADING TO NECROSIS. PHYSICIAN REPORTED NECROSIS TO A SUNEVA MEDICAL CLINICAL TRAINER ON (B)(6) 2017, ABOUT 6 DAYS AFTER ON-LABEL BELLAFILL INJECTION IN ACNE SCARS IN THE CHEEKS DURING A TRAINING ON (B)(6) 2017. IT IS UNKNOWN WHETHER ADDITIONAL INJECTIONS WERE PERFORMED AFTER THE TRAINING; HOWEVER THE NECROSIS APPEARS TO BE IN THE RIGHT LOWER MALAR CHEEK, JUST ABOVE THE RIGHT JAWLINE, WHICH APPEARS TO BE MUCH LOWER THAN THE AREAS OF INJECTION ON (B)(6) 2017. IT IS UNKNOWN IF ADDITIONAL MEDICAL INTERVENTION WAS CONDUCTED, BUT AT THE TIME OF THE REPORT THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE PRODUCT BY SQUEEZING THE AFFECTED AREA. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE ACCOUNT. 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 F171077) WITH NO ISSUES NOTED. RETAINED LOT SAMPLES OF LOT F171077 WERE REVIEWED 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." (B)(6).

    Description of Event or Problem · 1

    SUSPECTED VASCULAR OCCLUSION LEADING TO NECROSIS. PHYSICIAN REPORTED NECROSIS TO A SUNEVA MEDICAL CLINICAL TRAINER ON (B)(6) 2017, ABOUT 6 DAYS AFTER ON-LABEL BELLAFILL INJECTION IN ACNE SCARS IN THE CHEEKS DURING A TRAINING ON (B)(6) 2017. IT IS UNKNOWN WHETHER ADDITIONAL INJECTIONS WERE PERFORMED AFTER THE TRAINING; HOWEVER THE NECROSIS APPEARS TO BE IN THE RIGHT LOWER MALAR CHEEK, JUST ABOVE THE RIGHT JAWLINE, WHICH APPEARS TO BE MUCH LOWER THAN THE AREAS OF INJECTION ON (B)(6) 2017. IT IS UNKNOWN IF ADDITIONAL MEDICAL INTERVENTION WAS CONDUCTED, BUT AT THE TIME OF THE REPORT THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE PRODUCT BY SQUEEZING THE AFFECTED AREA. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851533 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F171077

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention