BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3536463 · Received December 6, 2013

    Report

    Report Number
    2135225-2013-00156
    Event Type
    Other
    Date Received
    December 6, 2013
    Report Date
    November 11, 2013
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INFO HAS BEEN REQUESTED FROM THE PT. NO FURTHER INFO HAS BEEN RECEIVED, THUS THE PT'S CURRENT STATUS IS UNK. THE DEVICE HISTORY RECORDS FOR THE RADIESSE LOT WERE NOT REVIEWED AS THE LOT NUMBER WAS UNK.

    Description of Event or Problem · 1

    THE PT INITIALLY CALLED AND LEFT A MESSAGE FOR CUSTOMER SERVICE, MERZ NORTH AMERICA TO STATE THAT SHE HAD SWELLING AND AN UNEVEN INJECTION OF RADIESSE. THE INJECTION WAS OVER SEAS TWO MONTHS AGE. THERE ARE LUMPS UNDER HER EYES. ON (B)(6) 2013, THE PT PROVIDED FURTHER INFO: SHE WAS INJECTED UNDER THE EYE ON APPROXIMATELY (B)(6) (IT WAS AT THE END OF (B)(6)) IN (B)(6) BY A LICENSED DERMATOLOGIST. THIS DERMATOLOGIST PREVIOUSLY DID HER FACE LIFT. AT TWO WEEKS POST INJECTION EVERYTHING LOOKED GOOD. AT THREE WEEKS POST INJECTION SHE WAS SWOLLEN AND WATERY. SHE WENT TO SEE A DOCTOR WHO REFERRED HER TO A PLASTIC SURGEON (PS). THE PS PRESCRIBED ANTIBIOTICS FOR 10 DAYS (NAME OF DRUG AND DOSE NOT PROVIDED, DIAGNOSIS NOT PROVIDED). SHE HAS UNEVEN LUMPS. TOMORROW ((B)(6) 2013) SHE IS GOING TO SEE A COSMETIC DERMATOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634938 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention