BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 12029627 · Received June 18, 2021

    Report

    Report Number
    3003707320-2021-00008
    Event Type
    Injury
    Date Received
    June 18, 2021
    Report Date
    June 18, 2021
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT STATES HER TEETH ARE FALLING OUT (9 SO FAR) RELATED TO A NOVA THREADS PROCEDURE THAT OCCURRED AT THE SAME TIME AS BELLAFILL DERMAL FILLER INJECTION. IN (B)(6) 2016. PATIENT ALSO RELAYS SHE WAS TOLD BY A DIFFERENT DOCTOR THAT THE THREADS ARE PUSHING THE BELLAFILL AROUND HER BODY. THE NAME OF THE DOCTOR WHO TOLD HER THIS IS UNKNOWN AT THIS TIME. THE PATIENT BELIEVES THERE IS PRODUCT COMING OUT OF HER FEET, TOES, FINGERS, FINGERTIPS, AND THAT IT'S IN HER MOUTH NOW. THE PATIENT STATES SHE HAS REPORTED HER ISSUES TO THE MAKERS OF THE PDO THREADS, NOVA THREADS, BUT RECEIVED NO HELP AND IS NOW CONTACTING SUNEVA. BACKGROUND: PATIENT HAD PREVIOUSLY CALLED SUNEVA IN (B)(6) 2017 FOR LUMPS IN HER FACE. HER BELLAFILL INJECTOR/PDO THREADS PROVIDER (DR. (B)(6)) HAD DISMISSED THE PATIENT FROM HER PRACTICE. PER THE DOCTOR SEEING HER SUBSEQUENT TO DR. (B)(6) IN 2017, DR. (B)(6), THERE IS NOTHING WRONG WITH BELLAFILL AND THE PATIENT HAS PSYCHIATRIC PROBLEMS. THE ISSUE AT THAT TIME WAS DETERMINED TO BE THE PDO THREADS WERE PLACED TOO SHALLOWLY AND THE PATIENT WAS INFORMED. TWO BELLAFILL LOTS WERE REPORTED BY THE PATIENT IN 2017 AS BEING USED IN HER BELLAFILL PROCEDURE IN (B)(6) 2016: F161013, UDI - (B)(4), EXP DATE: 06/07/2017, MANUFACTURING DATE: 02/09/2016. F161058, UDI - (B)(4), EXP DATE: 09/30/2017, MANUFACTURING DATE: 05/10/2016. BOTH LOTS WERE REVIEWED AND NO ISSUES WERE NOTED. SUNEVA HAS LEFT MESSAGES FOR THE PATIENT AT THE NUMBER PROVIDED AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME. SUNEVA WILL UPDATE THIS SUBMISSION IF ANY NEW INFORMATION IS RECEIVED. PATIENT RELAYS SHE WAS TOLD BY A CURRENT DOCTOR THAT THE THREADS ARE PUSHING THE BELLAFILL AROUND HER BODY. THE NAME OF THE DOCTOR WHO TOLD HER THIS IS UNKNOWN AT THIS TIME. 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."

    Description of Event or Problem · 1

    PATIENT STATES HER TEETH ARE FALLING OUT (9 SO FAR) RELATED TO A NOVA THREADS PROCEDURE THAT OCCURRED AT THE SAME TIME AS BELLAFILL DERMAL FILLER INJECTION. IN (B)(6) 2016. PATIENT ALSO RELAYS SHE WAS TOLD BY A DIFFERENT DOCTOR THAT THE THREADS ARE PUSHING THE BELLAFILL AROUND HER BODY. THE NAME OF THE DOCTOR WHO TOLD HER THIS IS UNKNOWN AT THIS TIME. THE PATIENT BELIEVES THERE IS PRODUCT COMING OUT OF HER FEET, TOES, FINGERS, FINGERTIPS, AND THAT IT'S IN HER MOUTH NOW. THE PATIENT STATES SHE HAS CONTACTED NOVA THREADS BUT RECEIVED NO HELP AND IS NOW CONTACTING SUNEVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922159 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F161013

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| S