BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 12029314 · Received June 18, 2021

    Report

    Report Number
    3003707320-2021-00007
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 18, 2021
    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
    117

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PRESENTING WITH SEVERE SWELLING IN FACE AND NECK ON (B)(6) 2021, THE DAY AFTER INJECTION OF 1 SYRINGE OF BELLAFILL DERMAL FILLER OFF-LABEL IN THE CHEEKS ON (B)(6) 2021. INJECTING ACCOUNT STATES THEY HAD TO SEND THE PATIENT TO URGENT CARE WHERE THEY RECEIVED TREATMENT. THE PATIENT HAS SINCE RESOLVED. TWO MONTHS PRIOR TO THE INJECTIONS OF (B)(6) 2021 (AND SUBSEQUENT SEVERE SWELLING ON (B)(6) 2021), THE PATIENT HAD 2 SYRINGES OF BELLAFILL WITHOUT ISSUES. AS SUCH, IT IS BELIEVED THAT IT IS UNLIKELY THAT BELLAFILL IS THE CAUSE OF THE PATIENT'S SEVERE SWELLING. THE INJECTING ACCOUNT STATES THAT WHEN THE PATIENT PRESENTED ON (B)(6) 2021 WITH SEVERE SWELLING, THE FACE WAS FULLY SWOLLEN AND THE NECK WAS STARTING TO SWELL. NO DIFFICULTY BREATHING, VITALS WERE NORMAL. NO DIFFICULTY IN VISION. THEY STATE THEY HAD TO SEND HER TO URGENT CARE WHERE SHE RECEIVED A STEROID INJECTION AND A STEROID PRESCRIPTION. AS OF (B)(6) 2021, THE ACCOUNT REPORTS THAT THE PATIENT HAS FULLY RECOVERED. BELLAFILL COMPLETED REVIEW OF THE LOT NUMBER USED IN THE PATIENT'S BELLAFILL PROCEDURE, LOT F211017. NO ISSUES WERE NOTED IN MANUFACTURING RECORDS OR IN RETAINED LOT SAMPLES. THE PATIENT WAS INJECTED WITH BELLAFILL OFF-LABEL IN THE CHEEKS. PER THE BELLAFILL INSTRUCTIONS FOR USE: 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 · 1

    PATIENT PRESENTING WITH SEVERE SWELLING IN FACE AND NECK ON (B)(6) 2021, THE DAY AFTER INJECTION OF 1 SYRINGE OF BELLAFILL DERMAL FILLER OFF-LABEL IN THE CHEEKS ON (B)(6) 2021. INJECTING ACCOUNT STATES THEY HAD TO SEND THE PATIENT TO URGENT CARE WHERE THEY RECEIVED TREATMENT. THE PATIENT HAS SINCE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922535 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F211017 10350224000025

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R