BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL DERMAL FILLER

    MDR report key: 8234434 · Received January 10, 2019

    Report

    Report Number
    3003707320-2019-00001
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    July 30, 2018
    Report Date
    January 9, 2019
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ((B)(6)) WAS INJECTED ON (B)(6) 2008. PER THE DOCTOR, BILATERAL GRANULOMA WAS FIRST DIAGNOSED IN (B)(6) 2010 AND AGAIN VIA BIOPSY TAKEN ON (B)(6) 2018. THE DOCTOR RELAYED THAT HE HAS TREATED THE GRANULOMA OFF AND ON WITH KENALOG, 5FU WITH RESULTING ATROPHY OF THE NASOLABIAL FOLDS WHICH WAS SEVERE AND IRREGULAR,REQUIRING EXCISION OF THE GRANULOMA AND RECONSTRUCTION OF THE NLF AS "THE ONLY SAFE AND REASONABLE OPTION." THE EXCISION OCCURRED ON 2 DATES: (B)(6) 2018 WITH EXCISION OF THE GRANULOMA ON THE LEFT NLF AND (B)(6) 2018 WITH EXCISION OF HTE GRANULOMA ON THE RIGHT NLF. THE PATIENT NOW "HAS A BILATERAL PERMANENT SCAR". THIS IS THE FIRST COMPLAINT REPORT OF GRANULOMA OR EXCISION FOR LOT F071100. LOT F071100 EXPIRED AS OF 07/2008; THEREFORE RETAINED SAMPLES ARE NOT AVAILABLE. REVIEW OF MANUFACTURING RECORDS FOUND NO ISSUES. THE LOT WAS MANUFACTURED IN ACCORDANCE WITH APPROVED WORK INSTRUCTIONS AND MET SPECIFICATIONS UPON RELEASE. ARTEFILL (AKA BELLAFILL) IS A SINGLE USE DEVICE. TREATMENT SYRINGES ARE "INTENTED" TO BE DISCARDED AT THE TIME OF INJECTION, PER THE 2007 ARTEFILL AND CURRENT BELLAFILL IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT." GRANULOMA IS AN ANTICIPATED PATIENT EVENT THAT IS DOCUMENTED IN THE ARTEFILL (NOW BELLAFILL) IFU. CLINICAL STUDIES SUPPORT THAT GRANULOMA MAY RESOLVE OVER TIME WITH OR WITHOUT TREATMENT.

    Description of Event or Problem · 1

    PATIENT WITH GRANULOMA REQUIRING EXCISION (ON (B)(6) 2018 AND (B)(6) 2018) OF BILATERAL GRANULOMA ON THE NASOLABIAL FOLDS. PER DOCTOR THIS HAS RESULTED IN A BILATERAL PERMANENT SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29667 ARTEFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. AF0508 F071100

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention| S