BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3413948 · Received October 9, 2013

    Report

    Report Number
    2135225-2013-00101
    Event Type
    Other
    Date Received
    October 9, 2013
    Date of Event
    September 6, 2013
    Report Date
    September 11, 2013
    Manufacturer
    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

    (B)(4). AT THE TIME OF THIS REPORT, THE PT HAS NOT BEEN IN FOR A F/U. NO FURTHER INFO HAS BEEN RECEIVED. THE DEVICE HISTORY RECORD FOR THE REPORTED RADIESSE LOT WAS REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECS FOR THIS LOT WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS INJECTED ON (B)(6) 2013 WITH 1.5CC OF RADIESSE. THE RADIESSE SYRINGE WAS MIXED WITH 0.3CC OVF LIDOCAINE. THE PT CALLED THE OFFICE ON (B)(6) 2013 AND STATED THAT SHE HAD A RASH. THE PT SENT PHOTOS TO THE INJECTING OFFICE (NOT RECEIVED BY MERZ). THE PT WAS OFFERED AN APPOINTMENT BUT SHE WENT TO URGENT CARE. ON (B)(6) 2013 ACYCLOVIR AND AUGMENTIN 875MG FOR 7 DAYS WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511725 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 100065971

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR THE RADIESSE SYRINGE WAS MIXED WITH,| 0.3CC OF LIDOCAINE