BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2161696 · Received July 8, 2011

    Report

    Report Number
    2135225-2011-00068
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PT WAS GIVEN PREDNISONE IN THE URGENT CARE FACILITY. THE PT WAS GIVEN AN INJECTION OF PREDNISONE IN THE EMERGENCY ROOM WEDNESDAY NIGHT, (B)(6) 2011. THE EMERGENCY ROOM ALSO GAVE THE PT AN ANTIHISTAMINE SHOT. THE PT GOT ORAL PREDNISONE FROM DR. (B)(6). THE PT HAD AN APPOINTMENT TO SEE DR. (B)(6) AGAIN ON MONDAY, (B)(6) 2011. PER THE GIRLFRIEND OF THE PT, THE PT GOT SOLUMEDROL WHEN IN THE EMERGENCY ROOM. THE PT HAS AN EPI PEN. THE PT HAS USED ICE AND KEPT HIS HEAD ELEVATED. NO PRESCRIPTIONS WERE GIVEN TO THE PT. FOLLOW UP INFO HAS BEEN REQUESTED BUT NOT RECEIVED. IF FOLLOW UP INFO IS RECEIVED, A FOLLOW UP MEDWATCH WILL BE SENT. TWO LOTS OF 1.5CC RADIESSE (B)(4) WERE USED ON THE PT. THE OTHER LOT NUMBER WAS 1020425 WITH AN EXPIRATION DATE OF (B)(6) 2012 AND A MANUFACTURE DATE OF 05/2010. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOTS WERE REVIEWED, ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 AT ABOUT 4:30PM, THE PT WAS INJECTED WITH TWO 1.5CC RADIESSE SYRINGES JUST BELOW THE NLF BY THE MARIONETTE LINES. THE PT STATED THAT AROUND 6:30-7PM HE FELT LIKE HE WAS HAVING AN EXTREME ALLERGIC REACTION. THE INJECTOR STATED THAT THE PT HAD SWELLING UP TO HIS EYES AND DOWN TO HIS NECK. THE PT TOLD THE INJECTOR THAT HE HAS HAD STRANGE ALLERGIC REACTIONS IN THE PAST. AT THE TIME OF THE INJECTION, THE PT WAS ON PAIN MEDICATIONS (NAME & DOSAGE NOT PROVIDED). THE PT WAS TAKEN TO AN URGENT CARE FACILITY AND THEN AFTER ASSESSMENT WAS THEN TAKEN BY AMBULANCE TO THE EMERGENCY ROOM. THE PT WENT TO EMERGENCY ROOM WITH REDNESS, SWELLING AND TIGHTNESS IN FACE. THE PT WAS HAVING A CHRONIC PAIN ISSUE AND THE EMERGENCY ROOM WOULD NOT GIVE HIM PAIN MEDICATION. THE PT SIGNED OUT OF THE EMERGENCY ROOM ON THE SAME DAY IN ORDER TO TAKE THE PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1017207

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R THE RADIESSE SYRINGE WAS MIXED WITH 0.3CC OF| LIDOCAINE.