BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3844661 · Received May 14, 2014

    Report

    Report Number
    2135225-2014-00026
    Event Type
    Other
    Date Received
    May 14, 2014
    Date of Event
    December 6, 2013
    Report Date
    April 22, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, THE RASH RESOLVED. IT WAS REPORTED THAT ALL OTHER EVENTS RESOLVED BY (B)(6) 2013. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECIFICATIONS FOR THIS LOT WERE MET PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A (B)(6) PHYSICIAN REPORTED THIS EVENT TO MERZ, (B)(4). ON (B)(6) 2013, DAY 8 AFTER TREATMENT WITH 3 CC OF RADIESSE DERMAL FILLER, A PATIENT PRESENTED SIGNIFICANT GENERALIZED FACIAL AND OCULAR EDEMA, RASH AND ERYTHEMA. THE SYMPTOMS BEGAN AT THE INJECTION POINTS AND TREATED AREAS AND THEN SPREAD ALL OVER THE FACE AND EYES. REPORTEDLY, THERE WAS EDEMA IN EYELID, ERYTHEMA AND ITCHING. THE PATIENT WENT TO URGENT SERVICE AND WAS HOSPITALIZED. THE DIAGNOSIS WAS INJECTABLE IMPLANT REACTION. CORRECTIVE TREATMENT COMPRISED OF INTRAVENOUS CORTICOSTEROIDS, ANTIBIOTICS AND ANTIHISTAMINE. THE ORAL TREATMENT LASTED FOR THREE WEEKS. THE PATIENT COULD NOT GO TO WORK DUE TO THE INTENSITY OF THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288573 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 100066440

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization DRUG THERAPY FOR RHEUMATOID ARTHRITIS,| NAME AND DATES UNKNOWN