BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 8843855 · Received July 30, 2019

    Report

    Report Number
    3003707320-2019-00009
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    January 1, 2019
    Report Date
    August 29, 2019
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP 1 (ADDITIONAL INFORMATION): - ON 07/30/2019, THE PATIENT REPORTS SWELLING THAT IS BEING TREATED WITH STEROID THERAPY AND HAS NOT RESOLVED. PATIENT ADDS SHE HAS LOCAL SWELLING UNDER EYES, TINGLING AND AT TIMES BURNING SENSATION. HER BELLAFILL INJECTOR (DR. SHAH) RELAYS SUBSEQUENTLY THE SAME DAY THAT THE PATIENT IS HAVING PERSISTENT SWELLING, THERE ARE NO PALPABLE LUMPS BUT HAD THE SWELLING AND WAS PUT ON KEFLEX. - ON (B)(6) 2019, ANOTHER TREATING PHYSICIAN'S OFFICE, (B)(6), RELAYED THEY HAD PRESCRIBED KEFLEX FOR SWELLING AND THEY ARE CONTEMPLATING EXCISION OF THE XANTHELASMA. (B)(6)- ON (B)(6) 2019, A PATIENT-FILED MEDWATCH MW5088754 WAS RECEIVED IN THE SUNEVA COMPLAINT DEPARTMENT (REPORT DATE: 07/31/2019), RELAYING SERIOUS INJURY REQUIRING INVERVENTION AND "BELLAFILL WAS PUT UNDER THE EYES. SWELLING IRRITATION AND BURNING NOTED 1 YEAR AFTER." "PREDINSONE, KEFLEX" WERE LISTED AS CONCOMITANT MEDICAL PRODUCTS. - UPDATED INFO IN THIS FOLLOW-UP 1 SUBMISSION: - SECTION A1: UPDATED PATIENT IDENTIFIER FROM T.S.B. TO "TSB AKA SG" TO ADD "AKA SG". THE PATIENT NAME PROVIDED IN MEDWATCH MW5088754 INCLUDED A DIFFERENT FULL NAME THAN WAS PROVIDED BY THE PATIENT AND REPORTED IN THE ORIGINAL MDR SUBMISSION. IT WAS CONFIRMED THIS WAS THE SAME PATIENT AS IN THE ORIGINAL SUBMISSION, BECAUSE THE NAME IN MW5088754 MATCHES THE PATIENT'S EMAIL ADDRESS. - SECTION B4: UPDATED FROM DATE OF ORIGINAL REPORT, WHICH WAS SUBMITTED ON (B)(6) 2019, TO THE DATE OF THIS FOLLOW-UP 1 REPORT, (B)(6) 2019. - SECTION B5: UPDATED TO ADD NEW INFORMATION RECEIVED AFTER ORIGINAL SUBMISSION THAT WAS DATED (B)(6) 2019 - SECTION D11: ADDED THE CONCOMITANT MEDICAL PRODUCTS MENTIONED BY THE PATIENT'S BELLAFILL INJECTOR, THE PATIENT'S CURRENT PROVIDER, AND THE PATIENT. ACTUAL DATE OF THERAPIES IS UNKNOWN, BUT IS SUSPECTED TO BE SOMETIME IN (B)(6) 2019. - SECTION G3: ADDED "OTHER" AND "PATIENT" TO INCLUDE THE PATIENT AS ANOTHER REPORT SOURCE. - SECTION G7: SELECTED "FOLLOW-UP" AND FOLLOW-UP NUMBER "1". - SECTION G8: ADDED TERMS: SWELLING, BURNING SENSATION, TINGLING, IRRITATION - SECTION H2: SELECTED "ADDITIONAL INFORMATION" - SECTION H6, PATIENT CODE: ADDED THE FOLLOWING CODES: 2091-SWELLING, 2146-BURNING SENSATION, 2171-TINGLING, AND 2076-IRRITATION SWELLING, BURNING SENSATION, TINGLING, AND INCREASED SENSITIVITY 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. ORIGINAL SUBMISSION, (B)(6) 2019 (NO CHANGE TO ORIGINAL INFOMATION PROVIDED): IN EARLY 2018, THE PATIENT WAS INJECTED WITH BELLAFILL DERMAL FILLER OFF-LABEL IN THE TEAR TROUGHS. ON (B)(6) 2019, THE PATIENT REPORTED YELLOWISH LUMPS UNDER THE EYES THAT HER DOCTOR, (B)(6), SUSPECTED WAS XANTHELASMA. ON (B)(6) 2019, THE DOCTOR CONFIRMED XANTHELASMA UNDER THE EYES. THERE ARE NO PALPABLE NODULES OR SWELLING UPON EXAM. WHILE XANTHELASMA IS NOT HARMFUL, IT DOES REQUIRE TREATMENT TO RESOLVE. THE DOCTOR IS CONSIDERING CO2 LASER TO ABLATE THE LESIONS. THE PATIENT WAS INJECTED OFF-LABEL IN THE TEAR TROUGHS ON 2 OCCASIONS IN EARLY 2018 BY DR. (B)(6): - (B)(6) 2018, LOT F171000, MODEL GBF0508, EXPIRATION DATE: 05/02/2018; MANUFACTURE DATE: 03/01/2017; UDI: (B)(4). 04/24/2018, LOT F171069, MODEL GBF0508, EXPIRATION DATE: 11/30/2018; MANUFACTURE DATE: 07/18/2017; UDI: (B)(4) F17106920181130 BOTH REPORTED LOTS (F171000 AND F171069) HAD EXPIRED AT THE TIME OF THE REPORT; THEREFORE, RETAINED LOT SAMPLES COULD NOT BE REVIEWED. MANUFACTURING RECORDS WERE REVIEWED FOR BOTH LOTS. NO ISSUES WERE NOTED. ALL LOTS WERE MANUFACTURED ACCORDING TO APPROVED WORK INSTRUCTIONS AND MET ALL ACCEPTANCE CRITERIA UPON RELEASE. THE PATIENT HAS NO KNOWN ISSUES WITH HIGH CHOLESTEROL. DR. (B)(6) IS AWARE OF BELLAFILL INDICATIONS FOR USE. BELLAFILL DERMAL FILLER IS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS IN CANADA. 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

    FOLLOW-UP 1: - ON (B)(6) 2019, THE PATIENT REPORTS SWELLING THAT IS BEING TREATED WITH STEROID THERAPY AND HAS NOT RESOLVED. PATIENT ADDS SHE HAS LOCAL SWELLING UNDER EYES, TINGLING AND AT TIMES BURNING SENSATION. HER BELLAFILL INJECTOR RELAYS SUBSEQUENTLY THE SAME DAY THAT THE PATIENT IS HAVING PERSISTENT SWELLING, THERE ARE NO PALPABLE LUMPS BUT HAD THE SWELLING AND WAS PUT ON KEFLEX. - ON (B)(6) 2019, ANOTHER TREATING PHYSICIAN'S OFFICE, NOT THE BELLAFILL INJECTOR, RELAYED THEY HAD PRESCRIBED KEFLEX FOR SWELLING AND ARE CONTEMPLATING EXCISION OF THE XANTHELASMA. - ON (B)(6) 2019, A PATIENT-FILED MEDWATCH MW5088754 WAS RECEIVED IN THE SUNEVA COMPLAINT DEPARTMENT, RELAYING SERIOUS INJURY REQUIRING INVERVENTION AND "BELLAFILL WAS PUT UNDER THE EYES. SWELLING IRRITATION AND BURNING NOTED 1 YEAR AFTER." "PREDINSONE, KEFLEX" WERE LISTED AS CONCOMITANT MEDICAL PRODUCTS. THE MEDWATCH REPORT DATE WAS 07/31/2019. (B)(6) 2019, ORIGINAL SUBMISSION: IN EARLY 2018, THE PATIENT WAS INJECTED WITH BELLAFILL DERMAL FILLER OFF-LABEL IN THE TEAR TROUGHS. ON (B)(6) 2019, THE PATIENT REPORTED YELLOWISH LUMPS UNDER THE EYES THAT HER DOCTOR SUSPECTED WAS XANTHELASMA. ON (B)(6) 2019, THE DOCTOR CONFIRMED XANTHELASMA. XANTHELASMA REQUIRES TREATMENT TO REMOVE. THE DOCTOR IS CONSIDERING CO2 LASER TO ABLATE THE LESIONS.

    Additional Manufacturer Narrative · 1

    IN EARLY 2018, THE PATIENT WAS INJECTED WITH BELLAFILL DERMAL FILLER OFF-LABEL IN THE TEAR TROUGHS. ON (B)(6) 2019, THE PATIENT REPORTED YELLOWISH LUMPS UNDER THE EYES THAT HER DOCTOR, DR. (B)(6), SUSPECTED WAS XANTHELASMA. ON (B)(6) 2019, THE DOCTOR CONFIRMED XANTHELASMA UNDER THE EYES. THERE ARE NO PALPABLE NODULES OR SWELLING UPON EXAM. WHILE XANTHELASMA IS NOT HARMFUL, IT DOES REQUIRE TREATMENT TO RESOLVE. THE DOCTOR IS CONSIDERING CO2 LASER TO ABLATE THE LESIONS. THE PATIENT WAS INJECTED OFF-LABEL IN THE TEAR TROUGHS ON 2 OCCASIONS IN EARLY 2018 BY DR. (B)(6): ON (B)(6) 2018, LOT F171000, MODEL GBF0508, EXPIRATION DATE: 05/02/2018; MANUFACTURE DATE: 03/01/2017; UDI: (B)(4); ON (B)(6) 2018, LOT F171069, MODEL GBF0508, EXPIRATION DATE: 11/30/2018; MANUFACTURE DATE: 07/18/2017; UDI: (B)(4). BOTH REPORTED LOTS (F171000 AND F171069) HAD EXPIRED AT THE TIME OF THE REPORT; THEREFORE, RETAINED LOT SAMPLES COULD NOT BE REVIEWED. MANUFACTURING RECORDS WERE REVIEWED FOR BOTH LOTS. NO ISSUES WERE NOTED. ALL LOTS WERE MANUFACTURED ACCORDING TO APPROVED WORK INSTRUCTIONS AND MET ALL ACCEPTANCE CRITERIA UPON RELEASE. THE PATIENT HAS NO KNOWN ISSUES WITH HIGH CHOLESTEROL. DR. (B)(6) IS AWARE OF BELLAFILL INDICATIONS FOR USE. BELLAFILL DERMAL FILLER IS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS IN CANADA. 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 · 1

    IN EARLY 2018, THE PATIENT WAS INJECTED WITH BELLAFILL DERMAL FILLER OFF-LABEL IN THE TEAR TROUGHS. ON (B)(6) 2019, THE PATIENT REPORTED YELLOWISH LUMPS UNDER THE EYES THAT HER DOCTOR SUSPECTED WAS XANTHELASMA. ON (B)(6) 2019, THE DOCTOR CONFIRMED XANTHELASMA. XANTHELASMA REQUIRES TREATMENT TO REMOVE. THE DOCTOR IS CONSIDERING CO2 LASER TO ABLATE THE LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633898 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F171000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention KEFLEX.| PREDISONE.