BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 7327336 · Received March 9, 2018

    Report

    Report Number
    2135225-2018-00010
    Event Type
    Injury
    Date Received
    March 9, 2018
    Report Date
    March 9, 2018
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    PKY
    UDI-DI
    M2138071M0K15
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATING MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD FOR RADIESSE DERMAL FILLER LOT 100089473 WAS REVIEWED. NO NON-CONFORMANCES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR EVENTS WERE NOTED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A (B)(6)-YEAR-OLD FEMALE PATIENT, A NURSE PRACTITIONER, WHO WAS INJECTED WITH 1CC OF RADIESSE ABOUT ONE MONTH AGO FOR HANDS INDICATION. CONCOMITANT MEDICATION REPORTED AS SYNTHROID (LEVOTHYROXINE). MEDICAL HISTORY POSITIVE FOR SULFA ALLERGY. RIGHT AFTER INJECTION (ALSO REPORTED AS (B)(6) 2018), THE PATIENT EXPERIENCED SWELLING, PINKNESS AND PAIN TO THE RIGHT HAND. IT WAS SO PAINFUL, SHE COULD NOT SLEEP THAT NIGHT. THE FOLLOWING DAY, SHE DEVELOPED THE SAME SYMPTOMS IN HER LEFT HAND. AN ORTHOPEDIC SURGEON FRIEND THOUGHT SHE HAD CELLULITIS AND STARTED HER ON AN UNSPECIFIED BROAD SPECTRUM ANTIBIOTIC. SHE DID NOT OTHERWISE SEE A PHYSICIAN. REPORTER CLARIFIED THE ANTIBIOTIC WAS NOT STARTED AS A PROPHYLACTIC MEASURE BUT AS TREATMENT. THE PATIENT EXPERIENCED IMPROVEMENT IN HER SYMPTOMS "RIGHT AFTER" STARTING ANTIBIOTIC. THE SYMPTOMS WERE RESOLVED AFTER THREE WEEKS. LOT NUMBER REPORTED AS 100089473.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169651 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE IN THE HANDS PKY MERZ NORTH AMERICA, INC. 8071M0K1 100089473 M2138071M0K15

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SYNTHROID