BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1851598 · Received September 28, 2010

    Report

    Report Number
    2135225-2010-00054
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 10, 2010
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS TREATED AT THE ER WITH IV ANTIBIOTICS, A MEDROL DOSE PACK AND RELEASED. PHOTOS OF THE PT HAS SHOWN THE PROGRESSION OF HEALING OF THE AFFECTED AREA. THE LOT NUMBER WAS NOT PROVIDED THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    PHYSICIAN ASSISTANT REPORTED A PT INJECTED WITH RADIESSE DERMAL FILLER IN THE NASO LABIAL FOLDS DEVELOPED IMMEDIATE SWELLING WITH BLISTERING OCCURRING SEVERAL HOURS LATER. THE PA INSTRUCTED THE PT TO GO TO URGENT CARE ONE DAY POST-INJECTION WHERE SHE WAS TREATED FOR A SEVERE ALLERGIC REACTION WITH STEROIDS, ANTIBIOTICS AND IM BENADRYL. THE FOLLOWING DAY SHOWED NO IMPROVEMENT AND THE PT WAS THEN INSTRUCTED TO GO TO THE ER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIESSE TREATMENT| JUVEDERM INJECTED ONE WEEK PRIOR TO