BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 12379966 · Received August 27, 2021

    Report

    Report Number
    3003707320-2020-00013
    Event Type
    Injury
    Date Received
    August 27, 2021
    Date of Event
    July 26, 2021
    Report Date
    August 27, 2021
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    UDI-DI
    10350224000025
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR REPORTED A PATIENT WITH INFECTION WHICH REQUIRED TREATMENT TO RESOLVE AFTER OFF-LABEL INJECTION OF BELLAFILL DERMAL FILLER IN THE LEFT LOWER CHEEK. THE DOCTOR RELAYS THAT THE PATIENT IS DOING WELL NOW WHEN THEY SAW HER LAST IN EARLY (B)(6) 2021. ADDITIONAL INFO: PER THE INJECTING PHYSICIAN, SHE ALWAYS PREPS THE SKIN WITH ALCOHOL AND NO OTHER SITES THAT SHE INJECTED WITH BELLAFILL ON THIS PATIENT ON THAT DAY HAD A PROBLEM. THE INFECTION WAS ONLY NOTED IN THE LEFT LOWER CHEEK.. WHEN THE PATIENT PRESENTED WITH ERYTHEMA, PAIN AND APPARENT FLUCTUANCE UNDER THE SKIN, SHE DRAINED THE AREA WITH AN 18G PUNCTURE WOUND AND GOT BACK ABOUT 1 CC OF PURULENT MATERIAL. UNFORTUNATELY SHE WAS NOT ABLE TO CULTURE THE MATERIAL AS SHE DOES NOT CARRY CULTURETTES IN HER OFFICE. SHE STARTED THE PATIENT ON A COURSE OF AUGMENTIN AT THAT TIME. THE NEXT DAY SHE SAW THE PATIENT AND THE AREA APPEARED BETTER BUT OUT OF AN ABUNDANCE OF CAUTION, SHE PERFORMED A PROPER INCISION AND DRAINAGE WITH A 1 CM INCISION BUT DID NOT SEE ANY MORE PUS. THE PATIENT REPORTS NO CONCOMITANT MEDICAL CONDITIONS. AS OF ~08/5/2021, THE PATIENT IS DOING WELL. BELLAFILL COMPLETED REVIEW OF THE LOT NUMBER USED IN THE PATIENT'S BELLAFILL PROCEDURE, LOT F211013. NO ISSUES WERE NOTED IN MANUFACTURING RECORDS OR IN RETAINED LOT SAMPLES. THE PATIENT WAS INJECTED WITH BELLAFILL OFF-LABEL IN THE LEFT LOWER CHEEK. 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

    DOCTOR REPORTED A PATIENT WITH INFECTION WHICH REQUIRED TREATMENT TO RESOLVE AFTER OFF-LABEL INJECTION OF BELLAFILL DERMAL FILLER IN THE LEFT LOWER CHEEK. THE DOCTOR RELAYS THAT THE PATIENT IS DOING WELL NOW WHEN THEY SAW HER LAST IN EARLY (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277389 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F211013 10350224000025

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention