BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2061249 · Received April 11, 2011

    Report

    Report Number
    2135225-2011-00019
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT FLEW CROSS-COUNTRY TO SAN FRANCISCO SEVERAL DAYS POST-INJECTION WHERE SHE DEVELOPED FURTHER SWELLING. SHE SAW A PHYSICIAN IN THE HOTEL WHO TREATED HER WITH AN ANTIHISTAMINE AND ANTIBIOTIC, AMOXICILLIN AS A PRECAUTION. AT THE END OF HER STAY, SHE DEVELOPED MAJOR SWELLING, ITCHING AND HIVES IN THE UNDER-EYE REGION. UPON ARRIVAL IN BOSTON, SHE SOUGHT TREATMENT AT THE EMERGENCY ROOM WHERE SHE WAS KEPT OVERNIGHT FOR OBSERVATION. SHE WAS PRESCRIBED PREDNISONE AND IS NOW DOING FINE WITH NO COMPLICATIONS. THE PT HAS HAD PREVIOUS ALLERGIC-TYPE REACTIONS TO CHINESE FOOD IN THE PAST AND STATED SHE HAD BEEN TO A (B)(6) WHILE ON VACATION. THE PT HAD NO SIGNS OF INFECTION. THE PHYSICIAN WILL PROVIDE SKIN ALLERGY TESTING IF THE PT DESIRES. IT IS UNK IF THE EVENT IS RADIESSE-RELATED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1013015 MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PT INJECTED IN THE MALAR AND INFRA-ORBITAL AREAS WITH RADIUS DEVELOPED ANGIOEDEMA WITH ONE EYE SWELLING SHUT 10 DAYS POST-INJECTION.

    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.) 1013015

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention