BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2090870 · Received May 6, 2011

    Report

    Report Number
    2135225-2011-00038
    Event Type
    Other
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG #: 8069M0K1. THE PT ALSO PROVIDED TREATMENT DETAILS: INITIAL TREATMENT WAS ICE X 15 MIN APPROX. Q30-45MIN; OXYCODONE/APAP 1/2 TO 1 TAB Q4H, INCREASED TO 1 TAB Q4H. ON (B)(6)-2011, STARTED BACTROBAN OINT BID ONGOING AND KEFLEX 500 MG QID X 5 DAYS. WARM COMPRESSES STARTED (B)(6)-2011 AND ONGOING. THE PT PUT HERSELF ON BEDREST FROM (B)(6)-2011. DR. (B)(6) INDICATED THAT DURING PHONE CONVERSATION, THE SYMPTOMS WERE RESOLVING, BUT THAT HE HAD NOT SEEN THE PT AGAIN SINCE (B)(6). THE RADIESSE LOT NUMBERS FOR THE 1.5CC OR 0.8CC SYRINGES USED WERE NOT PROVIDED BY DR. (B)(6) AT THIS TIME.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED INJECTING A PT WITH RADIESSE DERMAL FILLER, IN THE NL FOLDS AND MARIONETTE LINES ON (B)(6), 2011. ON FRIDAY ((B)(6) 2011), THE PT REPORTED A PRESSURE-FEELING AT THE LEFT NL FOLD. ON SATURDAY, THE PT CALLED AGAIN, TO REPORT SWELLING AND WHITE SPOTS NOTED. DR. (B)(6) SAW HER ON (B)(6) 2011, BUT DID NOT NOTE ANY NECROSIS OR BLANCHING, AND NO VISIBLE WHITE SPOTS, ALTHOUGH THE PT HAD TAKEN PHOTOS THAT MORNING. HE PRESCRIBED ORAL ANTIBIOTICS AND TOPICAL ANTIBIOTIC OINTMENT. THE PT FELT BETTER SUNDAY, BUT THEN MONDAY ((B)(6) 2011), THE LEFT NL FOLD HAD GOTTEN WORSE. ADD'L NOTES FROM THE PT (PROVIDED ON (B)(6) 2011), WITH SYMPTOMS STARTING ON (B)(6) 2011: SEVERE PAIN, EDEMA, ECCHYMOSIS, ERYTHEMA AND PITTING OF SKIN, HEADACHE, NUMBNESS/EDEMA/PAIN AFFECTING BREATHING AND ABILITY TO EAT/DRINK, NUMBNESS AFFECTING ABILITY TO BLINK/CLOSE EYE COMPLETELY, EXTREMELY PAINFUL SMALL WHITE LESIONS ON LEFT NOSE, NASOLABIAL FOLD, MEDIAL CHEEK WHICH PROGRESSED TO RUPTURE WITH THICK, WHITE EXUDATE AND SEROSANGUINOUS OOZING, PAINFUL SCABBING AT LEFT NL FOLD LEFT SIDE OF NOSE AND IN LEFT NARIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention