BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 4646029 · Received March 27, 2015

    Report

    Report Number
    2135225-2015-00021
    Event Type
    Other
    Date Received
    March 27, 2015
    Date of Event
    February 12, 2015
    Report Date
    March 6, 2015
    Manufacturer
    MERZ ANESTHETICS INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTEDLY, THE PT EXPERIENCED SWELLING OF THE WHOLE FACE. ADDITIONALLY, REDNESS AND SENSITIVITY-PAIN (AFFECTING THE WHOLE FACE) WERE REPORTED. CORRECTIVE TREATMENT INCLUDED CIPROPOL, AMERTIL, CLEMASTIN, FUROSEMID, DIPHROPHOS, AND METYPRED FROM (B)(6) 2015. THE EVENTS OF REDNESS AND PAIN RESOLVED ON (B)(6) 2015. THE EVENT OF SWELLING RESOLVED ON (B)(6) 2015. IN THE OPINION OF THE REPORTER, THE EVENTS WERE OF SEVERE INTENSITY BUT NOT CONSIDERED PERMANENT. ANTIBIOTIC INDICATION WAS REQUESTED AND NOT RECEIVED. THE DEVICE HISTORY RECORDS FOR THE INJECTED RADIESSE LOT WERE NOT REVIEWED AS THE LOT NUMBER WAS UNK.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM (B)(6) AND CONCERNS A (B)(6) FEMALE PT. SHE WAS INJECTED WITH RADIESSE INTO THE CHEEKS AND LIPS ON (B)(6) 2015. ON THE SAME DAY, A FEW HOURS POST-INJECTION, THE PT DEVELOPED SWELLING AT THE INJECTION SITE, AROUND THE MOUTH AND CHEEKS. FOLLOW-UP INFO WAS RECEIVED ON 04/06/2015. THE PT WAS INJECTED WITH 1.5 ML (0.8 ML RIGHT SIDE, 0.7 ML LEFT SIDE) USING LINEAR RANGE TECHNIQUE. THE NEEDLE USED FOR INJECTION WAS A 27 G CANNULA. FURTHER MED HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204854 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ ANESTHETICS INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention