BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 17713108 · Received September 8, 2023

    Report

    Report Number
    3003707320-2023-00012
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    July 27, 2023
    Report Date
    September 8, 2023
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    UDI-DI
    10350224000025
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL INTERVENTION AND HOSPITALIZATION FOR SEVERE SWELLING AFTER OFF-LABEL BELLAFILL INJECTION IN THE CHEEKS. PER PATIENT SHE RESOLVED 5 DAYS AFTER ONSET. PER PATIENT: SHE HAS HAD BELLAFILL DERMAL FILLER PREVIOUSLY WITH NO ISSUES. INJECTION DATE WAS (B)(6) 2023 AND SEVERE SWELLING OCCURRED THAT EVENING. SHE WENT TO THE HOSPITAL ON (B)(6) 2023 AND RECEIVED IV STEROIDS, PREDNISONE PACK, AND BENEDRYL. SHE RESOLVED 5 DAYS AFTER ONSET (B)(6) 2023. BELLAFILL PROVIDER: DR. (B)(6). SUBSEQUENT STATEMENTS PROVIDED BY THE BELLAFILL PROVIDER'S OFFICE: THE PATIENT, (B)(6), DOB (B)(6) 1986 HAS HAD A TOTAL OF 17 SYRINGES OF BELLAFILL BEGINNING (B)(6) 2018. AFTER SYRINGE #16 THE PATIENT HAD MILD FACIAL SWELLING AND DR. (B)(6) PRESCRIBED A MEDROL PACK. SHE WAS SCHEDULED ON (B)(6) 2023 FOR SYRINGE #17 AND DR. (B)(6) PRESCRIBED A MEDROL PACK FOR HER TO TAKE PRIOR TO THIS INJECTION. IT DID NOT WORK. THE PATIENT SOUGHT MEDICAL ATTENTION AND WAS GIVEN IV STEROIDS, SHE STATES SHE DID NOT HAVE DIFFICULTY BREATHING. BOTH THE 16TH AND 17TH SYRINGES WERE FROM THE SAME BELLAFILL DERMAL FILLER LOT F231017. MANUFACTURING RECORDS AND RETAINED LOT SAMPLES FROM LOT F231017 WERE REVIEWED WITH NO ISSUES NOTED. BELLAFILL. BELLAFILL DERMAL FILLER IS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS AND MODERATE TO SEVERE, ATROPHIC, DISTENSIBLE FACIAL ACNE SCARS ON THE CHEEK IN PATIENTS OVER THE AGE OF 21 YEARS. BELLAFILL SYRINGES ARE SINGLE USE DEVICES AND ARE TYPICALLY DISCARDED AFTER USE. PER THE BELLAFILL IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT."

    Description of Event or Problem · 0

    MEDICAL INTERVENTION AND HOSPITALIZATION FOR SEVERE SWELLING AFTER OFF-LABEL BELLAFILL INJECTION IN THE CHEEKS. PER PATIENT SHE RESOLVED 5 DAYS AFTER ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524593 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F231017 10350224000025

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization| R