BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RDIESSE DERMAL FILLER

    MDR report key: 2935142 · Received January 24, 2013

    Report

    Report Number
    2135225-2013-00002
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MERZ AESTHETICS INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN IS CONTINUING TO MONITOR THE PT. SHE HAS AN APPOINTMENT TO SEE AN OPHTHALMOLOGIST (B)(6) 2013. FOLLOW-UP REPORTED BY PHYSICIAN ON (B)(6) 2013 STATES THE OPHTHALMOLOGIST IS CONCERNED ABOUT SHRINKING AND DISCOLORATION OF THE EYEBALL (PHTHISIS BULBI). HER EYE MOVEMENT HAS SLIGHTLY IMPROVED DUE TO DECREASED SWELLING BUT HE IS CONCERNED ABOUT FUTURE MOVEMENT OF THE EYE. THE PT NOW HAS AN AREA ABOVE THE INJECTION SITE WHICH COULD POSSIBLY BE SHINGLES. THE PT IS CONTINUING TO BE MONITORED BY SEVERAL SPECIALIST PHYSICIANS. THE PT HAS NOT RETURNED TO THE INJECTING PHYSICIAN AT THIS TIME. THE DEVICE HISTORY RECORDS FOR REPORTED LOT #1033068 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THIS LOT WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED DURING THE MANUFACTURING OF THIS LOT.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED INJECTING THE PT IN THE MID-FOREHEAD REGION ABOVE THE LEFT EYEBROW WITH RADIESSE. THE PT HAS HAD THREE PREVIOUS RADIESSE INJECTIONS WITHOUT ISSUE. SHE HAD UNDERGONE A FAT TRANSFER AND FACE LIFT APPROXIMATELY SIX WEEKS PREVIOUSLY AND REQUESTED TO BE INJECTED WITH RADIESSE TO FILL IN THE AREA ABOVE HER LEFT EYEBROW. THE 5 MINUTES POST-PROCEDURE THE PT STATED SHE FELT HER EYE SHIFT TO THE LEFT. UPON EXAMINATION THIS WAS NOT OBSERVED. THE PT WENT TO THE LADIES ROOM AND DID NOT RETURN SO THEY SENT HER FRIEND IN TO FIND HER. WHEN SHE FINALLY RETURNED IT WAS OBVIOUS SHE WAS HAVING DIFFICULTY WITH THE RANGE OF MOTION IN HER EYE. DR (B)(6) IMMEDIATELY TOOK HER ACROSS THE HALL TO THE OPHTHALMOLOGIST. HE PERFORMED A CAST OF THE RETINAL ARTERY TREE; INSTEAD OF BEING FILLED WITH BLOOD IT WAS FILLED WITH WHITE PARTICULATE. HE ATTEMPTED TO RELEASE THE INTRAOCULAR PRESSURE AND MASSAGE. HE USED A MANNITOL DRIP TO TRY TO INCREASE THE CIRCULATION OF EYE, HOWEVER SHE CONTINUED TO HAVE DIFFICULTY WITH INTRAOCULAR MOTION. THE RETINA WILL NOT RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34901 RDIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS INC. 1033068

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O| S