BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2710122 · Received August 16, 2012

    Report

    Report Number
    2135225-2012-00082
    Event Type
    Other
    Date Received
    August 16, 2012
    Date of Event
    May 7, 2012
    Report Date
    July 27, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1023503 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS FORWARDED BY (B)(6), MERZ (B)(6). PT WAS INJECTED WITH RADIESSE FOR THE FILLING OF THE NASOLABIAL FOLDS. FORTY-EIGHT HOURS AFTER, APPEARANCE OF A PAINFUL INFLAMMATORY EDEMA WITH A SMALL ULCERATIVE LESION IN THE LEFT SUPRA-VESTIBULAR AREA. EVOLUTION TO THE APPEARANCE OF THE SUSPECT SEROUS IN THE NASOLABIAL FOLD. THE SEROUS SAMPLE WAS STERILE AT THAT MOMENT. PT WAS TREATED WITH AUGMENTIN (AMOXICILLIN + CLAVULANIC ACID) 1G X 2/J; SOLUPRED (PREDNISOLONE) 1 WEEK AND LOCAL TREATMENT WITH BISEPTINE AND MOUTHWASHES. ON (B)(4)2012, (B)(6) FORWARDED CASE UPDATE, "ON (B)(6) 2012, A (B)(6) FEMALE PT RECEIVED AN INJECTION OF RADIESSE FOR THE FILLING OF THE NASOLABIAL FOLDS, ALTOGETHER WITH AN INJECTION OF SURGIDERM IN THE LIPS. FORTY EIGHT HOURS AFTER INJECTION ((B)(6) 2012), THE PT CALL THE INJECTOR BECAUSE HER LEFT NASOLABIAL FOLD WAS PAINFUL. PICTURES HAVE BEEN TAKEN ON (B)(6) 2012 BY THE PHYSICIAN. THE PT ALSO PRESENTED SMALL ULCERATION OF THE VESTIBULE (SHE RECEIVED RECENTLY A DENTAL IMPLANT (BRIDGE). HOWEVER, THE GUM DID NOT SEEM TO SHOW ANYTHING SPECIAL). THE PHYSICIAN PRESCRIBED AN ANTIBIOTIC (AUGMENTIN) AND A CORTICOID TREATMENT (SOLUPRED) AND ADVISE HIS PT TO CONSULT HER DENTIST. FOUR DAYS AFTER INJECTION, THE PT CALLED THE PHYSICIAN AND CONSULTED HIM THE DAY AFTER BECAUSE SHE PRESENTED A PURULENT AND INFLAMMATORY LESION AT THE BASIS OF THE NOSE. A SAMPLE WAS TAKEN AND LOCAL ANTISEPTICS AND MOUTHWASHES WERE PRESCRIBED. THE BACTERIOLOGICAL ANALYSIS OF SAMPLES SHOWS THE SAMPLE WAS STERILE, AND NO POLYNUCLEAR WERE FOUND. THE PT HAS BEEN ADVISED AGAIN TO CONTACT HER DENTIST. ACCORDING TO THE PT, THE REACTION WAS SEVERE. HOWEVER, THE PHYSICIAN CONSIDERS SHE HAD DISCOMFORT FOR ABOUT 10 DAYS. IT SEEMS TO THE PHYSICIAN THAT THE PT RECEIVED NEW AESTHETIC TREATMENTS FROM ANOTHER PHYSICIAN SINCE THE LAST TIME HE SAW HER. TO DATE, THE PHYSICIAN DID NOT SEE THE PT AGAIN". AUGMENTIN (AMOXICILLIN + CLAVULANIC ACID) AND SOLUPRED (PREDNISOLONE) PRESCRIBED ON (B)(6) 2012, LOCAL ANTISEPTIC AND MOUTHWASHES PRESCRIBED ON (B)(6) 2012".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1023503

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SURGIDERM