BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2090097 · Received May 6, 2011

    Report

    Report Number
    2135225-2011-00030
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 15, 2011
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS ADMITTED TO THE HOSP FOR LARYNGEAL ANGIOEDEMA AND RESPIRATORY DISTRESS. SHE WAS RELEASED AFTER THREE DAYS STAY AND WAS REPORTED TO BE DOING WELL. THE TREATMENTS ADMINISTERED BY THE HOSP WERE NOT PROVIDED TO THE INJECTING PHYSICIAN. HER SYMPTOMS HAVE RESOLVED. NEITHER THE PT NOR THE PHYSICIAN BELIEVE THE RADIESSE WAS THE CAUSE OF HER ANGIOEDEMA. THE PHYSICIAN PLANS TO PERFORM A RADIESSE SKIN ALLERGY TEST ON THE PT AT A LATER DATE AS SHE WANTS TO CONTINUE RECEIVING RADIESSE TREATMENTS IN THE FUTURE. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT # 1023518 MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PT HE INJECTED WITH RADIESSE IN THE NASO LABIAL FOLDS WITHOUT INCIDENT. THE PT LEFT THE OFFICE FEELING FINE. WITHIN 36-48 HRS POST-INJECTION SHE WENT TO THE ER AFTER BEING UNABLE TO BREATHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1023518

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization