BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER (PREVIOUSLY KNOWN AS ARTEFILL DERMAL FILLER)

    MDR report key: 9240500 · Received October 25, 2019

    Report

    Report Number
    3003707320-2019-00020
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    June 1, 2017
    Report Date
    April 2, 2020
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP #1: ADDITIONAL INFORMATION WAS ADDED TO THE FOLLOWING SECTIONS: B5: ADDED: THE DOCTOR REPORTS ON 03/06/2020 THAT THE PRODUCT WAS EXPLANTED IN (B)(6) 2020 WITH RESULTING ORBITAL HEMORRHAGE (WHICH OCCURRED ON (B)(6) 2020). NO LOSS OF VISION. THE PATIENT REMAINS ON ANTIBIOTICS, CURRENTLY CLARITHROMYCIN AND CIPRO. D7: ADDED EXPLANT DATE OF (B)(6) 2020. THE SURGERY TO REMOVE THE BELLAFILL OCCURRED ~2 WEEKS PRIOR TO THE DOCTOR'S UPDATE TO SUNEVA ON 03/06/2020. THE EXACT DATE IS UNKNOWN. G7: ADDED FOLLOW-UP #1. H2: THIS FOLLOW UP IS TO PROVIDE ADDITIONAL INFORMATION. H6: ADDED PATIENT CODE 1888 (HEMORRHAGE). NARRATIVE FROM ORIGINAL MDR SUBMISSION OF 10/25/2019: MEDICAL INTERVENTION REQUIRED. PATIENT WITH RECURRING PRESEPTAL CELLULITIS IN THE LEFT MEDIAL EYELID AREA AFTER OFF-LABEL INJECTION OF BELLAFILL IN THE TEAR TROUGHS. PATIENT WAS INJECTED WITH BELLAFILL (PREVIOUSLY KNOWN AS ARTEFILL) ON TWO (2) OCCASIONS IN THE TEAR TROUGHS: ON (B)(6)2014, ARTEFILL DERMAL FILLER, MODEL: AF0508, LOT F141088, MANUFACTURE DATE: 10/17/2014, EXPIRATION DATE: 03/31/2016, UDI: N/A. ON (B)(6)2017, BELLAFILL DERMAL FILLER, MODEL GBF0508, LOT F161157, MANUFACTURE DATE: 12/21/2016: EXPIRATION DATE: 05/10/2018, UDI: (B)(4). THE CELLULITIS FIRST PRESENTED IN (B)(6) 2017. PATIENT HAS BEEN TREATED WITH BIAXIN X 3 WEEKS, 5FU, STEROID WEEKLY 9:1 X3. SHE'S ALSO UNDERGONE MULTIPLE IM STEROID INJECTIONS FROM HER ARTEFILL/BELLAFILL INJECTOR, AS WELL AS BEEN TREATED WITH COLCHICINE. DR. (B)(6) INDICATES HE CAN PALPATE SMALL 1 TO 2MM BEADS IN THE AREA. AT LAST CONTACT, DR. (B)(6) WAS PLANNING TO SEND SAMPLES TO A LAB FOR HISTOLOGY. THE REPORTING DOCTOR (DR. (B)(6)) WHO IS TREATING THE PATIENT'S CELLULITIS WAS NOT THE ARTEFILL/BELLAFILL INJECTOR. THE PATIENT WAS REFERRED TO DR. (B)(6) BY THE PATIENT'S ARTEFILL/BELLAFILL INJECTOR, DR. (B)(6). 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." BELLAFILL DERMAL FILLER 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.

    Description of Event or Problem · 0

    MEDICAL INTERVENTION REQUIRED. PATIENT WITH RECURRING PRESEPTAL CELLULITIS IN THE LEFT MEDIAL EYELID AREA AFTER OFF-LABEL INJECTION OF BELLAFILL IN THE TEAR TROUGHS. THE DOCTOR REPORTS ON 03/06/2020 THAT THE PRODUCT WAS EXPLANTED IN (B)(6) 2020 WITH RESULTING ORBITAL HEMORRHAGE (WHICH OCCURRED ON 03/05/2020). NO LOSS OF VISION. THE PATIENT REMAINS ON ANTIBIOTICS, CURRENTLY CLARITHROMYCIN AND CIPRO.

    Additional Manufacturer Narrative · 1

    MEDICAL INTERVENTION REQUIRED. PATIENT WITH RECURRING PRESEPTAL CELLULITIS IN THE LEFT MEDIAL EYELID AREA AFTER OFF-LABEL INJECTION OF BELLAFILL IN THE TEAR TROUGHS. PATIENT WAS INJECTED WITH BELLAFILL (PREVIOUSLY KNOWN AS ARTEFILL) ON TWO (2) OCCASIONS IN THE TEAR TROUGHS: (B)(6) 2014, ARTEFILL DERMAL FILLER, MODEL: AF0508, LOT F141088, MANUFACTURE DATE: 10/17/2014, EXPIRATION DATE: 03/31/2016, UDI: N/A. (B)(6) 2017, BELLAFILL DERMAL FILLER, MODEL GBF0508, LOT F161157, MANUFACTURE DATE: 12/21/2016, EXPIRATION DATE: 05/10/2018, UDI: (B)(4). THE CELLULITIS FIRST PRESENTED IN (B)(6) 2017. PATIENT HAS BEEN TREATED WITH BIAXIN X 3 WEEKS, 5FU, STEROID WEEKLY 9:1 X3. SHE'S ALSO UNDERGONE MULTIPLE IM STEROID INJECTIONS FROM HER ARTEFILL/BELLAFILL INJECTOR, AS WELL AS BEEN TREATED WITH COLCHICINE. DR. (B)(6) INDICATES HE CAN PALPATE SMALL 1 TO 2 MM BEADS IN THE AREA. AT LAST CONTACT, DR. (B)(6) WAS PLANNING TO SEND SAMPLES TO A LAB FOR HISTOLOGY. THE REPORTING DOCTOR (DR. (B)(6)) WHO IS TREATING THE PATIENT'S CELLULITIS WAS NOT THE ARTEFILL/BELLAFILL INJECTOR. THE PATIENT WAS REFERRED TO DR. (B)(6) BY THE PATIENT'S ARTEFILL/BELLAFILL INJECTOR, DR. (B)(6). 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." BELLAFILL DERMAL FILLER 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.

    Description of Event or Problem · 1

    MEDICAL INTERVENTION REQUIRED. PATIENT WITH RECURRING PRESEPTAL CELLULITIS IN THE LEFT MEDIAL EYELID AREA AFTER OFF-LABEL INJECTION OF BELLAFILL IN THE TEAR TROUGHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033184 BELLAFILL DERMAL FILLER (PREVIOUSLY KNOWN AS ARTEFILL DERMAL FILLER) IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. AF0508 F141088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention