BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2739283 · Received September 4, 2012

    Report

    Report Number
    2135225-2012-00102
    Event Type
    Other
    Date Received
    September 4, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 6, 2012
    Manufacturer
    MERZ AESTHETICS, INC
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THE LOT WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THE PT INITIALLY CONTACTED MERZ AESTHETICS VIA EMAIL STATING, "I AM EXPERIENCING SEVERE SWELLING AND HEAT 10 DAYS POST-INJECTION. MY DOCTOR'S "MEDSPA" IS CLOSED ON MONDAY AND THERE IS NO ANSWERING SERVICE. PLEASE CALL ME ASAP." FROM DISCUSSION OVER THE PHONE WITH THE PT ON THE SAME DAY ((B)(6) 2012): (B)(6) STATED THAT SHE WENT TO DR. (B)(6) AS HER FACE HAD DROPPED. SHE WANTED BUILD UP AROUND CHEEKBONE AREA BUT DR. (B)(6) WAS WORRIED AS THE PT HAS A PRONOUNCED JAWLINE. DR. (B)(6) DID NOT WANT TO HAVE A DOUBLE-BUBBLE EFFECT. THE DOCTOR TRIED TO ROUND IT OUT. WHEN SHE LEFT THE OFFICE SHE WAS A TINY BIT LOP-SIDED. IT WAS HARDLY NOTICEABLE. (B)(6) SAID THERE WAS SOME SWELLING THE NEXT DAY AND THEN SHE WAS FINE. YESTERDAY MORNING ((B)(6) 2012) SHE WOKE UP AND AROUND HER EYES IT LOOKED LIKE IT WAS DRAINING. (B)(6) HAD NO FEVER THIS MORNING ((B)(6)2012). SHE SAID FEVER MAY BE COMING ON NOW (SHE FEELS WEIRD LIKE HAVING A REACTION) BUT SINCE SHE IS TAKING IBUPROFEN IT IS HARD TO TELL. THE PROBLEM IS ON HER LEFT SIDE. SHE HAS A HEAD-ACHE ABOVE HER EYE WHICH SHE SAYS REFERRED PAIN. HER HUSBAND IS A GASTROENTEROLOGIST. DR. (B)(6) OFFICE IS CLOSED ON MONDAY AND NO ONE RETURNS THE MESSAGE THAT SHE LEFT. MEDICATIONS THAT THE PT HAS USED SO FAR: BENADRYL LAST NIGHT, NORMAL DOSE, FEXOFENADINE 180MG, IBUPROFIN, DEZONIDE 0.05 CREAM THAT SHE HAD ALREADY. ICE ON AND OFF EVERY HOUR. THE PT WAS CALLED AGAIN ON (B)(4) 2012 AND SHE STATED THAT DR. (B)(6) ((B)(6)) HAD CALLED HER BACK. AT THE TIME OF THE CALL SHE HAD JUST LEFT DR. (B)(6) OFFICE. DR. (B)(6) PRESCRIBED PREDNISONE AND ZYTHROMAX. THE DOCTOR THOUGHT THAT THERE MIGHT BE AN INFECTION. ON (B)(6) 2012 THE DOCTOR'S OFFICE WAS CALLED AND THE PT IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC 1033085

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention