BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2177107 · Received July 15, 2011

    Report

    Report Number
    2135225-2011-00061
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    March 23, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT RETURNED TO INJECTING PHYSICIAN ON (B)(6) 2011 WITH PERSISTING SYMPTOMS AND WAS TREATED WITH A SECOND COURSE OF CIPRO, PREDNISONE AND NEWLY PRESCRIBED CLINDAMYCIN. DURING A F/U APPOINTMENT IN (B)(6), 2011, THE PHYSICIAN ATTEMPTED TO EXCISE THE RADIESSE WITHOUT SUCCESS. KENALOG WAS INJECTED INTO EACH AREA AND A MEDROL DOSE PACK PRESCRIBED. PT RETURNED TO THE INJECTING PHYSICIAN ON (B)(6) 2011, PRESENTING WITH MILD TO MODERATE ERYTHEMA AT LEFT CHEEK AND PREDNISONE WAS CONTINUED. FURTHER F/U HAS NOT BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1024009 MET ALL SPECS PRIOR TO RELEASE AND NO ABNORMALITIES WERE NOTED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PT INJECTED WITH RADIESSE IN THE NASOLABIAL FOLDS, ORAL COMMISSURES AND MARIONETTE LINES DEVELOPED SEVERE SWELLING AND CYST-LIKE AREAS ON LEFT SIDE OF FACE SEVERAL DAYS POST-INJECTION. THE PT WENT TO THE ER AND WAS TREATED WITH BACTRIM. THE INJECTING PHYSICIAN ALSO PRESCRIBED CIPRO AND PREDNISONE FOR HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1024009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention