BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 23711010 · Received December 3, 2025

    Report

    Report Number
    3003707320-2025-00012
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    August 23, 2025
    Report Date
    February 24, 2026
    Manufacturer
    TIGER AESTHETICS MEDICAL LLC
    Product Code
    LMH
    UDI-DI
    10350224000025
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP 1: AS OF (B)(6)2026, PER BELLAFILL INJECTOR, "ALLERGY" IS NO LONGER SUSPECTED. THE PATIENT'S NEW PROVIDER SUSPECTS BIOFILM INFECTION THAT WAS INTRODUCED AT THE TIME OF THE BELLAFILL INJECTION, CAUSED BY BACTERIA ON THE FACE. MEDICAL INTERVENTION IS REQUIRED. PER INJECTING ACCOUNT, PATIENT WAS INJECTED IIN BOTH THE TEMPLES AND IN THE CHEEKS. NO FURTHER INFORMATION HAS BEEN RECEIVED. B3: DATE OF EVENT - 08/25/2025: DATE OF INJECTION AND ONSET OF SYMPTOMS. E: INFORMATION FOR REPORTER WHO PROVIDED NEW INFORMATION AS OF 01/25/26 ADDED TO THIS SECTION. G3: DATE RECEIVED BY MANUFACTURER - 01/25/26: DATE COMPANY RECEIVED ADDITONAL INFORMATION/CORRECTION FOR THIS FOLLOW-UP REPORT. H6: UPDATED TO REFLECT NEW INFORMATION ONLY - UPDATED HEALTH EFFECT-CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, AND INVESTIGATION CONCLUSIONS. PATIENT'S NEW PROVIDER - NOTE: PATIENT WOULD NOT ALLOW THE COMPANY TO CONTACT THIS PROVIDER. DR. (B)(6). PER THE BELLAFILL INSTRUCTIONS FOR USE: THE DIRECTIONS FOR USE SECTION INCLUDES THE FOLLOWING INSTRUCTION, "7. AFTER ENSURING THAT THE PATIENT HAS THOROUGHLY WASHED THE TREATMENT AREA WITH SOAP AND WATER, THE AREA SHOULD BE CLEANED WITH ALCOHOL OR OTHER ANTISEPTIC."

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, PATIENT REPORTS SEVERE SWELLING, BREATHING ISSUES, PAIN, AND REDNESS THAT OCCURRED SAME DAY AS OFF-LABEL INJECTION IN THE TEMPLES. INJECTIONS OCCURRED ON (B)(6) 2025. PATIENT WAS PUT ON A COURSE OF STEROIDS, BENEDRYL, AND TOPICALS. PER PATIENT HER PRIMARY DOCTOR ENCOURAGED HER TO GO TO THE ER, BUT THE PATIENT CHOSE NOT TO. AT TIME OF THE INITIAL REPORT, PATIENT WAS NOT HAVING BREATHING ISSUES AND THE SWELLING HAD GONE DOWN. PER THE INJECTOR, THE PATIENT HAD PREVIOUSLY HAD 2 KITS OF BELLAFILL WITH NO ISSUES, SO A SKIN TEST WAS NOT DONE BEFORE THE PATIENT'S INJECTIONS. PER INJECTOR, ANOTHER PROVIDER HAD INJECTED THE PATIENT WITH OTHER TYPES OF FILLERS PREVIOUSLY (TYPES UNKNOWN), SO THE INJECTOR IS NOT CONVINCED THIS IS A BELLAFILL ISSUE. A BELLAFILL SKIN TEST IS PLANNED FOR DECEMBER TO SEE IF THERE IS ANY RESPONSE. ALLERGIC REACTION IS SUSPECTED. OTHER RELEVANT HISTORY: - OTHER FILLERS USED PRIOR TO BELLAFILL INJECTIONS (UNKNOWN). - PATIENT STOPPED TAKING A GLP-1 DRUG ABOUT 6 WEEKS PRIOR TO REPORT DATE OF (B)(6) 2025. PER THE BELLAFILL INSTRUCTIONS FOR USE: - 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. - A BELLAFILL SKIN TEST MUST BE ADMINISTERED AND EVALUATED PRIOR TO INJECTION OF BELLAFILL. PATIENTS DEMONSTRATING A POSITIVE SKIN TEST, OR 2 EQUIVOCAL SKIN TESTS SHOULD NOT BE CONSIDERED CANDIDATES FOR TREATMENT. B3: DATE OF EVENT - 08/25/2025: DATE OF INJECTION AND ONSET OF SYMPTOMS. D9: DEVICE NOT AVAILABLE FOR EVALUATION. BELLAFILL SYRINGES ARE SINGLE USE DEVICES THAT ARE TYPICALLY DISCARDED AFTER USE. PER BELLAFILL IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT." G3: DATE RECEIVED BY MANUFACTURER - 11/07/2025: DATE OF INITIAL REPORT. BELLAFILL INJECTOR: (B)(6).

    Description of Event or Problem · 0

    FOLLOW-UP 1: AS OF (B)(6)2026, PER BELLAFILL INJECTOR, "ALLERGY" IS NO LONGER SUSPECTED. THE PATIENT'S NEW PROVIDER SUSPECTS BIOFILM INFECTION THAT WAS INTRODUCED AT THE TIME OF THE BELLAFILL INJECTION, CAUSED BY BACTERIA ON THE FACE. MEDICAL INTERVENTION IS REQUIRED. PER INJECTING ACCOUNT, PATIENT WAS INJECTED IIN BOTH THE TEMPLES AND IN THE CHEEKS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, PATIENT REPORTS SEVERE SWELLING, BREATHING ISSUES, PAIN, AND REDNESS THAT OCCURRED SAME DAY AS OFF-LABEL INJECTION IN THE TEMPLES. INJECTIONS OCCURRED ON (B)(6) 2025. PATIENT WAS PUT ON A COURSE OF STEROIDS, BENEDRYL, AND TOPICALS. PER PATIENT HER PRIMARY DOCTOR ENCOURAGED HER TO GO TO THE ER, BUT THE PATIENT CHOSE NOT TO. AT TIME OF THE INITIAL REPORT, PATIENT WAS NOT HAVING BREATHING ISSUES AND THE SWELLING HAD GONE DOWN. PER THE INJECTOR, THE PATIENT HAD PREVIOUSLY HAD 2 KITS OF BELLAFILL WITH NO ISSUES, SO A SKIN TEST WAS NOT DONE BEFORE THE PATIENT'S INJECTIONS. PER INJECTOR, ANOTHER PROVIDER HAD INJECTED THE PATIENT WITH OTHER TYPES OF FILLERS PREVIOUSLY (TYPES UNKNOWN), SO THE INJECTOR IS NOT CONVINCED THIS IS A BELLAFILL ISSUE. A BELLAFILL SKIN TEST IS PLANNED FOR DECEMBER TO SEE IF THERE IS ANY RESPONSE. ALLERGIC REACTION IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2853582 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 F251029 10350224000025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention