BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1855809 · Received October 1, 2010

    Report

    Report Number
    2135225-2010-00057
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 3, 2010
    Manufacturer
    MERZ AESTHETICS INC. (FORMERLY BIOFORM MEDICAL INC.)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, THE REPORTING PHYSICIAN PROVIDED THE FOLLOWING INFO: THE PT HAD CALLED THE PHYSICIAN WITHIN 48 HOURS OF THE RADIESSE INJECTION. THE PT STATED THAT SHE WAS ALL RED IN THE INJECTED AREAS. THE PHYSICIAN WENT TO SEE THE PT AND THE PT'S NOSE WAS SWOLLEN, VERY RED AND EDEMATOUS. THE SITE WAS TENDER TO THE TOUCH. THE PHYSICIAN KEPT SEEING THE PT EVERY COUPLE OF DAYS. SHE STATED THAT THE PT DEVELOPED CELLULITIS. THE PT WAS PRESCRIBED KEFLEX AND THEN WENT TO URGENT CARE TO SEE A PHYSICIAN THAT SHE HAS GONE TO FOR 14 YEARS. THAT PHYSICIAN PRESCRIBED AUGMENTIN. NOW (AS OF (B)(6) 2010 THE AREA IS ALMOST HEALED. THE REDNESS CAN BE SEEN AT THE LEFT NARIS AT THE CURVED DEPRESSION. THE REDNESS IS ALMOST GONE. EMOLLIENTS HAVE HELPED THE SCABBING AND THE ANTIBIOTICS HAVE ALSO HELPED THE PT. THE PHYSICIAN KEPT THE SYRINGE. AFTER SHE INJECTED ABOUT 1/2 INTO THE PT, SHE TAPPED THE SYRINGE (KEPT IT PLUGGED). SHE INDICATED THAT IN ONE MONTH SHE IS PLANNING TO USE THE SAME SYRINGE AGAIN FOR THIS PT. (B)(6) HAS ADVISED THE PHYSICIAN THAT THE RADIESSE SYRINGE IS A SINGLE USE DEVICE. ON (B)(6) 2010, THE REPORTING PHYSICIAN PROVIDED THE FOLLOWING INFO. THE PHYSICIAN OBTAINED A CULTURE AND IT CAME BACK AS STREP. THE AFFECTED AREA CRUSTED OVER AND HAS NOW HEALED UP BUT DID TAKE UPWARDS OF 2 WEEKS. THERE WAS A UNILATERAL PRESENTATION.

    Description of Event or Problem · 1

    THE PT WAS INJECTED ABOUT A WEEK AND A HALF PRIOR TO THE REPORT DATE OF (B)(6) 2010 BY THE REPORTING PHYSICIAN. THE PT WAS INJECTED IN THE JUNCTION BETWEEN THE NOSE AND FOREHEAD, THE MID 1/3 OF THE NOSE, AND THE NASOLABIAL FOLDS. THE PT HAD A REACTION THAT INCLUDED SCABBING AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS INC. (FORMERLY BIOFORM MEDICAL INC.) 1018249

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention