BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL DERMAL FILLER

    MDR report key: 15442563 · Received September 16, 2022

    Report

    Report Number
    3003707320-2022-00006
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 16, 2022
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTED ON (B)(6) 2022 THAT MEDICAL INTERVENTION (SURGERY) IS REQUIRED FOR GRANULOMA AND SWELLING AFTER OFF-LABEL ARTEFILL DERMAL FILLER INJECTION UNDER THE EYES IN 2015. PER PT: NO OTHER FILLERS IN AREA. NO MEDICAL CONDITIONS AS FAR AS SHE IS AWARE. HOWEVER, PATIENT PREVIOUSLY HAD SURGERY OF THE AREA (MALAR IMPLANTS) PRIOR TO HER ARTEFILL (A.K.A. BELLAFILL) INJECTIONS. DATE OF EVENT: (B)(6) 2022 IS THE DATE THE PATIENT REPORTED THAT MEDICAL INTERVENTION (SURGERY) WAS REQUIRED. IT IS UNKNOWN AT THIS TIME WHETHER THE SURGERY HAS OCCURRED. WAITING FOR RESPONSE FROM THE PATIENT'S DOCTOR. ESTIMATED ONSET DATE OF THE GRANULOMA AND SWELLING IS (B)(6) 2020. (B)(4). IT IS UNKNOWN AT THIS TIME WHETHER THE SURGERY HAS OCCURRED. WAITING FOR RESPONSE FROM THE PATIENT'S DOCTOR. THREE (3) LOTS WERE USED IN THE PATIENT'S ARTEFILL DERMAL FILLER PROCEDURE ON (B)(6) 2015. F141060: PRE UDI REQUIREMENT; EXPIRATION DATE: 12/31/2015; MANUFACTURE DATE: 07/14/2014. F141065: PRE UDI REQUIREMENT; EXPIRATION DATE: 01/31/2016; MANUFACTURE DATE: 08/01/2014. F141067: PRE UDI REQUIREMENT; EXPIRATION DATE: 01/31/2016; MANUFACTURE DATE: 08/07/2014. NO ISSUES WERE NOTED WITH REVIEW OF MANUFACTURING RECORDS FOR THE LOTS USED IN THE PATIENT'S PROCEDURE. THE LOTS HAVE SINCE EXPIRED THEREFORE RETAINED SAMPLES WERE NOT AVAILABLE FOR REVIEW. BELLAFILL 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. GRANULOMA AND SWELLING ARE ANTICIPATED PATIENT EVENTS THAT ARE DOCUMENTED IN THE BELLAFILL IFU. CLINICAL STUDIES SUPPORT THAT THESE ISSUES MAY RESOLVE OVER TIME WITH OR WITHOUT TREATMENT. 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

    PATIENT REPORTED ON (B)(6) 2022 THAT MEDICAL INTERVENTION (SURGERY) IS REQUIRED FOR GRANULOMA AND SWELLING AFTER OFF-LABEL ARTEFILL DERMAL FILLER INJECTION UNDER THE EYES IN 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124736 ARTEFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. AF0508 F141060

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention MALAR IMPLANTS - DATE UNKNOWN