BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1243775 · Received November 24, 2008

    Report

    Report Number
    2135225-2008-00067
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 24, 2008
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SEEN AT THE OFFICE THE NEXT DAY AND REPORTED THE REDNESS WAS DISSIPATING AND WAS LESS SORE TO THE TOUCH. HOWEVER, SHE HAD DEVELOPED A SLIGHT FEVER AND STREAKS TRAVELING UP HER FOREARM. THE PHYSICIAN PRESCRIBED KEFLEX FOR THE PATIENT. DURING FOLLOW-UP, IT WAS REPORTED THE SYMPTOMS ARE RESOLVING AND THE PATIENT IS FEELING BETTER EACH DAY. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED LOTS; #1011125 AND 1011288 MET ALL SPECIFICATIONS. A REVIEW OF BIOFORM MEDICAL'S ADVERSE EVENT DATABASE WAS CONDUCTED FOR LOTS #1011125 AND 1011288. NO OTHER REPORTED INFECTIONS WERE REVEALED FOR EITHER LOT. ADDITIONAL LOT# 1011288.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PATIENT INJECTED WITH RADIESSE DERMAL FILLER IN THE HANDS IS EXPERIENCING SWELLING, REDNESS AND IS SORE TO THE TOUCH IN ONE HAND, TWO DAYS POST-INJECTION. THE PHYSICIAN IS CONCERNED THERE MAY BE AN INFECTION DEVELOPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1011125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention