BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2132462 · Received June 13, 2011

    Report

    Report Number
    2135225-2011-00059
    Event Type
    Other
    Date Received
    June 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL AFFAIRS CONSULT WAS SET-UP FOR THE PT (SINCE SHE IS A MEDICAL PRACTITIONER HERSELF) WITH (B)(6). THE PT REPORTED THAT THE ORAL MUCOSA LESIONS HAD DEVELOPED WITHIN THE FIRST 24-48 HOURS POST INJECTION. THE PT HAD INFORMED THE INJECTOR, DR. (B)(6) AND WAS TOLD THAT PERHAPS A SMALL VESSEL WAS OCCLUDED. DR. (B)(6) HAD TO LEAVE FOR (B)(6) AND THEREFORE SELF-TREATED WITH ORAL ANTIBIOTICS. SHE BLISTERED WITH SMALL VESICLES ON HER NLF AND UPPER LIP WHICH RESOLVED IN 5 DAYS. SHE IS DOING MUCH BETTER NOW BUT DESCRIBED SEVERE PAIN FOR THE FIRST 3-4 DAYS POST-INJECTION. (B)(6) ALSO INDICATED THAT THE PERSISTENT REDNESS MAY BE THAT OF HEALING TISSUE. THE PT'S INFECTION HAD RESOLVED AT THE TIME THIS EVENT HAD BEEN REPORTED. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1016033 WERE REVIEWED. ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE; THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THE PT (ALSO A PHYSICIAN) WAS INJECTED WITH ONE SYRINGE OF RADIESSE DERMAL FILLER TO THE NL FOLDS, BY DR. (B)(6) ON (B)(6) 2011. THE PT HAD IMMEDIATE REDNESS AND THE FOLLOWING DAY ((B)(6) 2011), THE LEFT SIDE WAS QUITE PAINFUL. SHE DEVELOPED REDNESS AND BLISTERS INSIDE AND OUTSIDE OF THE MOUTH. THE PT SELF-TREATED WITH A HIGH DOSE ANTIBIOTICS AND ANTI-VIRAL. THE SWELLING, PAIN, BLISTERS HAD SUBSIDED ABOUT ONE WEEK AFTER STARTING MEDICATION. THE PT REPORTED THIS EVENT TO (B)(4) DUE TO PROLONGED REDNESS OF THE LEFT UPPER LIP AND LEFT LOWER NL FOLD. SINCE THE PT REPORTED THAT SHE DEVELOPED AN INFECTION, ONE DAY POST RADIESSE TREATMENT, THIS MEDWATCH REPORT WILL CAPTURE THAT AE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1016033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention