BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 8923683 · Received August 22, 2019

    Report

    Report Number
    3003707320-2019-00014
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    August 22, 2019
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ((B)(6)) WAS INJECTED OFF-LABEL IN THE HANDS WITH BELLAFILL DERMAL FILLER (LOT F151107) ON (B)(6) 2015. INJECTOR INFO: DR. (B)(6), MD, (B)(6) ON (B)(6) 2019, THE PATIENT REPORTED NERVE PAIN CAUSED BY A GRANULOMA IN HER RIGHT HAND THAT WAS "SITTING ON A NERVE". ON 08/15/2019, THE PATIENT'S CURRENT PROVIDER, (B)(6) PAC AT (B)(6), INDICATES THAT TO ALLEVIATE THE NERVE PAIN, TREATMENT (CORTISONE INJECTIONS) IS REQUIRED TO SHRINK THE NODULE/SUSPECTED GRANULOMA. PER THE CURRENT PROVIDER A BIOPSY HAS NOT BEEN DONE TO CONFIRM GRANULOMA. 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. MANUFACTURING RECORDS FOR LOT F151107 WERE REVIEWED AND NO ISSUES WERE NOTED. THE LOT WAS MANUFACTURED ACCORDING TO APPROVED WORK INSTRUCTIONS AND MET ALL ACCEPTANCE CRITERIA UPON RELEASE. THE LOT HAS SINCE EXPIRED (EXPIRATION DATE: 01/31/2017); THEREFORE, RETAINED LOT SAMPLES WERE NOT AVAILABLE FOR REVIEW. BELLAFILL SYRINGES ARE SINGLE USE DEVICES THAT ARE TYPICALLY DISCARDED AFTER USE. PER THE BELLAFILL IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT." NODULES AND/OR GRANULOMA ARE ANTICIPATED PATIENT EVENTS THAT ARE DOCUMENTED IN THE BELLAFILL INSTRUCTIONS FOR USE. CLINICAL STUDIES SUPPORT THAT THESE ISSUES MAY RESOLVE OVER TIME WITH OR WITHOUT TREATMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT REPORTED NERVE PAIN CAUSED BY A GRANULOMA IN HER RIGHT HAND THAT WAS "SITTING ON A NERVE". ON 08/15/2019, THE PATIENT'S CURRENT PROVIDER INDICATES THAT TO ALLEVIATE THE NERVE PAIN, TREATMENT (CORTISONE INJECTIONS) IS REQUIRED TO SHRINK THE NODULE/SUSPECTED GRANULOMA. THE PATIENT HAD PREVIOUSLY BEEN INJECTED WITH BELLAFILL DERMAL FILLER OFF-LABEL IN THE HANDS ON (B)(6) 2015, BY A DIFFERENT PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714965 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F151107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention