BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 6231345 · Received January 6, 2017

    Report

    Report Number
    3003707320-2017-00002
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    October 7, 2016
    Report Date
    January 6, 2017
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EVALUATED BECAUSE BELLAFILL IS A SINGLE USE DEVICE AND THE SYRINGE WAS DISCARDED BY THE INJECTOR AFTER USE. MANUFACTURING RECORDS WERE REVIEWED FOR LOT F161066 WITH NO ISSUES NOTED. RETAINED LOT SAMPLES OF LOT F161066 WERE REVIEWED WITH NO ISSUES NOTED. THE PATIENT WAS INJECTED IN THE BILATERAL NASOLABIAL FOLDS (NLF), MID-FACE AND IN THE LOWER COMMISSURES. THE ABSCESS WAS NOTED NEAR ONE NLF. NO ISSUES WERE NOTED WITH THE OTHER AREAS INJECTED WITH BELLAFILL. PRODUCT LABELING PRECAUTIONS INJECTORS "AS WITH ALL TRANSCUTANEOUS PROCEDURES, BELLAFILL INJECTION CARRIES A RISK OF INFECTION. THE USUAL PRECAUTIONS ASSOCIATED WITH INJECTABLE MATERIALS SHOULD BE FOLLOWED." WHILE THE TREATING PRACTITIONER INDICATED THAT MEDICAL INTERVENTION WAS REQUIRED TO RESOLVE THE ABSCESS AND THE ABSCESS DID RESOLVE AS A RESULT, IT IS UNKNOWN WHETHER THE MEDICAL INTERVENTION (ANTIBIOTICS) MIGHT HAVE ULTIMATELY PREVENTED ANY SERIOUS INJURY (I.E. PERMANENT IMPAIRMENT OR DAMAGE).

    Description of Event or Problem · 1

    PATIENT WITH ABSCESS REQUIRING ANTIBIOTICS TO RESOLVE. ON (B)(6) 2016: PATIENT INJECTED WITH BELLAFILL IN THE NASOLABIAL FOLDS (NLF), AS WELL AS OFF-LABEL IN THE MID-FACE AND LOWER COMMISSURES. ON (B)(6) 2016: PATIENT CAME BACK TO THE INJECTOR WITH A 2CM AREA OF FIRMESS NEAR THE NLF. NO OTHER AREAS WERE AFFECTED. ON (B)(6) 2016: INJECTOR CONTACTED (B)(6) MEDICAL TO REPORT PATIENT WITH A 2CM NODULE NEAR THE NLF, PALPABLE, NOT VISIBLE, BUT TENDER WHEN TOUCHED. INJECTOR RECOMMENDS THAT PATIENT GENTLY MASSAGE THE AREA AT THAT TIME. THERE WAS NO INDICATION AT THAT TIME OF A MALFUNCTION, OR INDICATION THAT THE PATIENT'S SYMPTOMS ARE LIFE-THREATENING, OR WOULD RESULT IN PERMANENT INJURY OR DEATH, OR WOULD REQUIRE MEDICAL INTERVENTION TO PREVENT THESE OUTCOMES. ON (B)(6) 2016: INJECTOR RELAYS TO (B)(6) MEDICAL THAT WHAT WAS THOUGHT TO BE A NODULE WAS ACTUALLY AN ABSCESS THAT WAS OOZING FROM THE POINT OF BELLAFILL INJECTION. INJECTOR PRESCRIBED ANTIBIOTICS/KEFLEX AND THE AREA IS NOW RESOLVED. ON (B)(6) 2016: INJECTOR FURTHER RELAYS TO (B)(6) MEDICAL THAT IT'S POSSIBLE THE ABSCESS MAY HAVE RESOLVED ON ITS OWN, BUT THEIR GUESS IS THAT IT WOULD HAVE NEEDED THE ANTIBIOTICS TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11256 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F161066

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention