BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 15601169 · Received October 13, 2022

    Report

    Report Number
    3003707320-2022-00007
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    September 14, 2022
    Report Date
    October 13, 2022
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WAS INJECTED WITH BELLAFILL DERMAL FILLER IN MULTIPLE OFF-LABEL AREAS IN 2015 AND 2016. AS OF (B)(6) 2022 PATIENT RELAYS HARDENED AREAS AND PAIN THAT PATIENT INDICATES ARE PERMANENT. PATIENT WAS ENCOURAGED TO SEE DOCTOR FOR EXAM OF CURRENT ISSUES, BUT HAS NOT AT THE TIME OF THIS REPORT. (B)(6) 2022 IS THE DATE THE PATIENT INDICATED THAT THE PAIN AND HARDNESS WERE PERMANENT. THREE (3) LOTS WERE USED IN THE PATIENT'S BELLAFILL DERMAL FILLER PROCEDURES: LOT F151003, EXP 06/02/2016, UDI CODE: (B)(4). INJECTION DATE: 02/16/2015, MANUFACTURER DATE: 01/13/2015. LOT F151008, EXP 06/17/2016, UDI CODE: (B)(4). INJECTION DATE: 03/25/1015, MANUFACTURE DATE: 02/03/2015. LOT F151053, EXP 10/08/2016, UDI CODE: (B)(4). INJECTION DATE: 01/07/2016, MANUFACTURE DATE: 05/11/2015. 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 ARE NOT AVAILABLE FOR REVIEW. BELLAFILL INJECTOR: (B)(6). OTHER DOCTOR: (B)(6). NOTE: DR. (B)(6). HAD SEEN THE PATIENT PREVIOUSLY FOR NODULES AND SWELLING IUNDER THE EYES AND BELOW THE CHEEKBONES SUSPECTED TO BE BELLAFILL-RELATED IN 2017. AT LAST CONTACT WITH THE PATIENT IN 2018, DR. (B)(6). STATES THE PATIENT HAD RESOLVED FROM THOSE ISSUES AND HAD NOT SEEN THE PATIENT SINCE THEN. PATIENT HAS STATED SHE WOULD NOT BE GOING BACK TO DR. (B)(6). AND IS NOT SURE NOW WHETHER SHE WILL BE SEEING DR. HANSEN FOR CURRENT ISSUES OR CHOOSING ANOTHER PROVIDER. PATIENT WAS INJECTED OFF-LABEL IUNDER THE EYES IN 2015 AND IN THE TEMPLES, CHIN AREAS AND UNDER THE CHEEKBONES IN 2016. 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. HARDNESS 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 WAS INJECTED WITH BELLAFILL DERMAL FILLER IN MULTIPLE OFF-LABEL AREAS IN 2015 AND 2016. AS OF (B)(6) 2022 PATIENT RELAYS HARDENED AREAS AND PAIN THAT PATIENT INDICATES ARE PERMANENT. PATIENT WAS ENCOURAGED TO SEE DOCTOR FOR EXAM OF CURRENT ISSUES, BUT HAS NOT AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972495 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F151003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability