BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2097596 · Received May 13, 2011

    Report

    Report Number
    2135225-2011-00043
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN TREATED HERSELF WITH KEFLEX AND ALSO INJECTED KENALOG INTO THE AFFECTED AREA. SHE PERFORMED AN IPL TREATMENT WITH LITTLE EFFECT. SHE WAS ABLE TO EMIT CLEAR DRAINAGE FROM THE INDURATED CYST BUT DID NOT CULTURE THE DRAINAGE. SHE REFERRED TO THIS AS A BIOFILM. DURING FOLLOW-UP, IT WAS REPORTED THE INDURATION HAS RESOLVED; HOWEVER, SOME SLIGHT DISCOLORATION REMAINS. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1022987 MET ALL SPECIFICATIONS PRIOR TO RELEASE. WE REGRET THE DELAY IN THE FILING OF THIS MATTER.

    Description of Event or Problem · 1

    PHYSICIAN WHO IS ALSO THE PT WAS INJECTED WITH RADIESSE ON (B)(6) 2011, AND BELIEVES SHE WAS INJECTED SUPERFICIALLY AND DEVELOPED A BIOFILM. SHE LATER REPORTED A FIRM INDURATED AREA ONE MONTH POST-INJECTION. SHE IMMEDIATELY BEGAN A COURSE OF ANTIBIOTIC KEFLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1022987

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention