BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2907276 · Received January 4, 2013

    Report

    Report Number
    2135225-2013-00001
    Event Type
    Other
    Date Received
    January 4, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED REPORTED LOT 1032125 MET ALL SPECS PRIOR TO RELEASE. THE PT'S RECOVERY STATUS WAS REQUESTED AND NOT RECEIVED TO DATE.

    Description of Event or Problem · 1

    PT'S ADVERSE EVENT WAS FORWARDED TO MERZ AESTHETICS, INC FROM (B)(6). THE INITIAL COMPLAINT CAME FROM (B)(6). (B)(6) INJECTED A FEMALE PT WITH 1.5 CC RADIESSE ON (B)(6) 2012 IN FOLDS AND CHEEK WITH A CANNULA. THE PT RECEIVED ANTIBIOTIC PROPHYLAXIS WITH BAYCIP 500 MG (1 TABLET/8 H). ON (B)(6) 2012, THE PHYSICIAN RECEIVED A CALL FROM THE PT STATING THAT SHE HAS A SIGNIFICANT EDEMA IN THE LEFT SIDE OF THE HEMIFACE AND AN INDURATION IN THE TREATED AREA. ON (B)(6) 2012, THE INVOLVED PT GOES TO A CLINICAL REVIEW, WHERE THE PHYSICIAN OBSERVED CELLULITE IN LEFT NASOLABIAL FOLD AND EDEMA AROUND THE LEFT SIDE OF THE HEMIFACE. THE PHYSICIAN EXPLORED THE AREA AND SHE STATED THAT IS HARD, BUT NOT FLUCTUATING. URBASON 60 IM WAS INDICATED AND THE PHYSICIAN ALSO INCREASED THE ANTIBIOTIC DOSE TREATMENT (AMOXICILLIN/CLAVULANIC 875/125 EACH 8 HOURS). THE PHYSICIAN RECOMMENDED TO THE PT INMUNOVEN AS HOMEOPATHIC IMMUNE BOOSTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5076 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1032125

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention