BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3844662 · Received May 14, 2014

    Report

    Report Number
    2135225-2014-00030
    Event Type
    Other
    Date Received
    May 14, 2014
    Date of Event
    April 20, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP ON (B)(4) 2014, MEDICAL ASSISTANT, REPORTED THE PATIENT IS HEALING WELL BUT SLOWLY. HE STATED THE VINEGAR SOAKS MADE HIS SKIN DRY AND CRACKED SO HE DISCONTINUED THE SOAKS AND SELF-TREATED WITH TEA TREE OIL. THE RADIESSE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, MEDICAL ASSISTANT AT THE (B)(6) REPORTED A PATIENT INJECTED WITH RADIESSE DERMAL FILLER BY CLINIC COORDINATOR, (B)(6), LPN DEVELOPED NECROSIS. THE PATIENT WAS INJECTED WITH TWO (1.5 CC) SYRINGES FOR HIV FACIAL LIPOATROPHY ON (B)(6) 2014. THE LEFT CHEEK AREA BECAME RED AND PAINFUL AND THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2014 WITH AN AREA OF NECROSIS ON HIS LEFT CHEEK. THE PATIENT WAS INSTRUCTED TO KEEP THE AREA CLEAN AND USE VINEGAR SOAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288671 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention MIXED WITH LIDOCAINE