BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATERFILL DERMAL FILLER

    MDR report key: 12207432 · Received July 21, 2021

    Report

    Report Number
    3003707320-2021-00011
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 19, 2021
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS INJECTED BETWEEN 2010 AND 2013. PATIENT DEVELOP A RAISED RIDGES IN THE NASAL LABIAL FOLD IN 2019. PATIENT MEDICAL HISTORY: PATIENT IS (B)(6) YEARS OLD WITH A GOOD HEALTH HISTORY AND GOOD HEALTH DURING CURRENT ISSUE. 5/05/2021: A REVIEWED OF THE 5FU/KENALOG 10 PROTOCOL WAS SEND TO DOCTOR TO TREAT PATIENT. 6/25/2021: PER DOCTOR, AN EXCISION WAS REQUIRED TO RESOLVE THE PATIENT'S ISSUE OF RAISED RIDGES IN THE NLF. THE ARTEFILL LOT USED IN THE PATIENT'S PROCEDURE (F111002) WAS REVIEWED. THE LOT WAS MANUFACTURED ACCORDING TO APPROVED WORK INSTRUCTIONS AND MET ALL ACCEPTANCE CRITERIA UPON RELEASE. THE LOT HAS SINCE EXPIRED (AS OF 07/31/2012) THEREFORE RETAINED LOT SAMPLES ARE NOT AVAILABLE FOR REVIEW. THIS IS THE FIRST REPORT OF SUSPECTED BIOFILM AND THE FIRST REPORT OF ISSUE FOR LOT F111002. THE ARTEFILL LOT USED IN THE PATIENT'S PROCEDURE (F121019) WAS REVIEWED. THE LOT WAS MANUFACTURED ACCORDING TO APPROVED WORK INSTRUCTIONS AND MET ALL ACCEPTANCE CRITERIA UPON RELEASE. THE LOT HAS SINCE EXPIRED (AS OF 09/30/2013) THEREFORE RETAINED LOT SAMPLES ARE NOT AVAILABLE FOR REVIEW. THIS IS THE FIRST REPORT OF SUSPECTED BIOFILM AND THE FIRST REPORT OF ISSUE FOR LOT F121019. AT THE TIME OF THE INJECTIONS, ARTEFILL DERMAL FILLER WAS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS. THE ARTEFILL (NOW BELLAFILL) IFU CONTAINS THE FOLLOWING PRECAUTION: "AS WITH ALL TRANSCUTANEOUS PROCEDURES, ARTEFILL (NOW BELLAFILL) INJECTION CARRIES A RISK OF INFECTION. THE USUAL PRECAUTIONS ASSOCIATED WITH INJECTABLE MATERIALS SHOULD BE FOLLOWED." ARTEFILL (NOW BELLAFILL) SYRINGES ARE SINGLE USE DEVICES AND ARE TYPICALLY DISCARDED AFTER USE. PER THE ARTEFILL (NOW BELLAFILL) IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT."

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH RAISED RIDGES IN THE NASAL LABIAL FOLD AREA. PATIENT IS A HEALTHY (B)(6) YR OLD THAT WAS INJECTED BETWEEN 2010 AND 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101926 ATERFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE, PRODUCT CODE: LMH LMH SUNEVA MEDICAL, INC. AF0508 F111002 / F121009

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R