BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2912906 · Received December 19, 2012

    Report

    Report Number
    2135225-2012-00151
    Event Type
    Other
    Date Received
    December 19, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MERZ AESTHETICS, INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO: CATALOG #8069M0K1, LOT #1031071, EXPIRATION DATE: 12/2013. ADD'L DATE - (B)(6) 2011. (B)(4). PER DISCUSSION WITH (B)(6) ON (B)(4) 2012: SHE IS RESOLVING. THERE IS A SCAR ON THE LEFT SIDE NOSTRIL. THE REDNESS IS EXPECTED TO LAST ONE YEAR. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THE PT CARE COORDINATOR (PCC) AT FACE PLUS WAS INJECTED BY A MERZ AESTHETICS FIELD CLINICAL SPECIALIST (FCS) ON (B)(6) 2012 AT NOON IN THE NLF AREA. THIS REPORT WAS RECEIVED FROM THE PCC. AFTER THE INJECTION HER FACE HURT. THERE WAS BLISTERS UNDER HER LIP AND HER LIP WAS SWOLLEN. WITHIN 48 HRS SHE PUT NITRATE IN THE WOUND. SHE STATED THAT THERE WERE PIMPLES IN THE NOSE AND ON THE SIDE OF HER FACE. DURING THIS TIME SHE WAS VERY CONCERNED ABOUT THE DRAINAGE THAT CAME OUT. WITHIN 3 DAYS THEY WOULD STARTED CLOSING DOWN. BY (B)(6) HER NOSE WAS NECROTIC AND PUSTULAR. SHE WAS ABLE TO LIFT UP THE LEFT SIDE OF THE NOSTRIL. ON (B)(6) SHE CALLED DR (B)(6). SHE DISCUSSED THE CASE WITH HIM AND HE TOLD HER TO SEE DR (B)(6) (AT THE OFFICE). SHE WAS STARTED ON KEFLEX (DATES, DOSE AND DURATION NOT PROVIDED). THE (B)(6) AFTER THE INJECTION INSIDE THE NOSE WAS PUSTULAR AND ON ONE SIDE OF THE NOSE IT WAS PUSTULAR. THE FOLLOWING WEEKEND SHE THOUGHT SHE HAD A (B)(6) AND WENT ON A STRONGER ANTIBIOTIC FOR ONE WEEK, CLINDAMYCIN (3 OR 4 TIMES PER DAY FOR 1 WEEK). DR (B)(6) STATED THAT THE REDNESS WOULD LAST A YEAR AND HE GAVE HER A ROSACEA CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC 1035576

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention