BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2550736 · Received April 20, 2012

    Report

    Report Number
    2135225-2012-00042
    Event Type
    Other
    Date Received
    April 20, 2012
    Date of Event
    February 1, 2011
    Report Date
    March 6, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALSO REQUIRED EXCISION OF RADIESSE. DR (B)(6) HAS NOT RESPONDED TO A REQUEST FOR FURTHER INFORMATION. THE RADIESSE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THE LOT WERE MET PRIOR TO RELEASE.

    Description of Event or Problem · 1

    DR (B)(6) REPORTED THAT THE PATIENT HAD THREE (3) SYRINGES OF THE SAME LOT NUMBER (1023085) INJECTED IN THE BILATERAL CHEEK AND PRE-JOWL AREA ON (B)(6) 2011. SHE SUBSEQUENTLY DEVELOPED PAIN, ERYTHEMA AND SWELLING IN THE LEFT CHEEK AREA STARTING IN THE BEGINNING OF (B)(6) 2011, AND ULTIMATELY WAS TREATED WITH IV VANCOMYCIN AND THEN FINALLY UNDERWENT EXTENSIVE SURGICAL EXCISION OF DEEP FACIAL RADIESSE DEPOSITS FELT TO BE RELATED TO AN INFECTIOUS BIOFILM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1023085

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention