BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1910173 · Received November 22, 2010

    Report

    Report Number
    2135225-2010-00086
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 1, 2010
    Manufacturer
    MERZ AESTHETICS, INC. (FORMERY 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

    THE PT WAS TREATED WITH A SECOND COURSE OF KEFLEX AND TOPICAL CORTICOSTEROID, TEMOVATE CREAM (PRESCRIBED TWO DAYS ON, TWO DAYS OFF). THE INFLAMMATION SLOWLY BEGAN TO RESOLVE. THE PT RETURNED FOR A RE-CHECK ON DAY FOURTEEN, SHOWING SIGNS OF IMPROVEMENT; HOWEVER, THE PUSTULES NOW APPEARED TO BE BUBBLING. THE PT WAS SENT TO A DERMATOLOGIST FOR FURTHER EVAL. DURING F/U THE PT COORDINATOR REPORTED THE PT IS NOW DOING WELL. NO FURTHER INFO HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES REPORTED LOT #1021358 MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    NURSE REPORTED A PT INJECTED WITH RADIESSE DERMAL FILLER IN THE NASOLABIAL FOLDS AND CHEEKS DEVELOPED AN AREA OF SWELLING, ERYTHEMA AND TENDERNESS TWO DAYS POST-INJECTION. THE PT WAS TREATED WITH ANTIBIOTIC, KEFLEX AND DARVOCET FOR PAIN. SHE WAS RE-EVALUATED ON DAY SIX WITH REDNESS SUBSIDING; HOWEVER, NOW SCAB-LIKE PUSTULES HAD FORMED WITH TISSUE THICKENING IN THE AFFECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. (FORMERY BIOFORM MEDICAL, INC.) 1021358

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention