BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 7135488 · Received December 20, 2017

    Report

    Report Number
    3003707320-2017-00014
    Event Type
    Injury
    Date Received
    December 20, 2017
    Report Date
    December 20, 2017
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEVELOPED LUMPS AFTER OFF-LABEL INJECTION OF BELLAFILL UNDER THE EYES BY HER INJECTOR (WHO IS ALSO THE PATIENT'S EMPLOYER AND THE PATIENT HAS REQUESTED NO CONTACT). ANOTHER DOCTOR (DR. (B)(6)) WHO IS TREATING THE PATIENT STATES THE INJECTIONS WERE TOO SHALLOW AND THE LUMPS ARE DUE TO POOR TECHNIQUE. DR. (B)(6) ALSO STATES THAT THE LUMPS CANNOT BE RESOLVED WITHOUT SURGERY; HOWEVER THE PATIENT DOES NOT WANT SURGERY, SO THE DOCTOR HAS BEEN CAMOUFLAGING INSTEAD WITH A HYALURONIC ACID DERMAL FILLER. THE PATIENT/EMPLOYEE WAS INJECTED OFF-LABEL UNDER THE EYES TWO (2) TIMES WITH BELLAFILL BY HER EMPLOYER: (B)(6) 2017, BELLAFILL LOT F171010, MODEL GBF0208, (B)(4), EXPIRATION DATE: 05/21/2018, MANUFACTURE DATE: 03/07/2017. ON (B)(6) 2017, BELLAFILL LOT F171037, MODEL GBF0208, (B)(4), EXPIRATION DATE: 09/16/2018, MANUFACTURE DATE: 05/02/2017. RETAINED SAMPLES FROM BOTH LOTS WERE REVIEWED WITH NO ISSUES NOTED. MANUFACTURING RECORDS FOR BOTH LOTS WERE REVIEWED WITH NO ISSUES NOTED.

    Description of Event or Problem · 1

    PATIENT DEVELOPED LUMPS AFTER OFF-LABEL INJECTION OF BELLAFILL UNDER THE EYES BY HER INJECTOR (WHO IS ALSO THE PATIENT'S EMPLOYER). ANOTHER DOCTOR (DR. (B)(6)) WHO IS TREATING THE PATIENT STATES THE INJECTIONS WERE TOO SHALLOW AND THE LUMPS ARE DUE TO POOR TECHNIQUE. DR. (B)(6) ALSO STATES THAT THE LUMPS CANNOT BE RESOLVED WITHOUT SURGERY; HOWEVER THE PATIENT DOES NOT WANT SURGERY, SO THE DOCTOR HAS BEEN CAMOUFLAGING INSTEAD WITH A HYALURONIC ACID DERMAL FILLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914681 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0208 F171010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention