BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3982646 · Received July 25, 2014

    Report

    Report Number
    2135225-2014-00045
    Event Type
    Other
    Date Received
    July 25, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE INJECTED RADIESSE LOT WERE NOT REVIEWED AS THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED INJECTING A FEMALE PATIENT WITH RADIESSE INTO NASOLABIAL FOLDS, THE PATIENT IS EXPERIENCING PAIN. ON (B)(6) 2014 AND (B)(6) 2014, DR. (B)(6) SPOKE WITH (B)(6), DR. (B)(6). DR. (B)(6) INJECTED RADIESSE INTO THE MARIONETTE LINES AND NASOLABIAL FOLDS OF A PATIENT ON (B)(6) 2014. POST OPERATIVELY THE PATIENT COMPLAINED OF PAIN. HE EXAMINED THE PATIENT ON FRIDAY AND NOTED MUCOSAL NECROSIS OF THE UPPER LIP AND ORAL COMMISSURE ON THE LEFT SIDE. DR. (B)(6) WAS ADVISED THAT AT FOUR DAYS AFTER INJECTION IT IS ALL ABOUT WOUND CARE. HE WAS ADVISED TO CONSIDER PROPHYLACTIC ANTIBIOTICS, ANTIVIRALS, AQUAPHOR, AVOIDANCE OF SMOKING, HEAD ELEVATION, ASPIRIN, POTENTIALLY MEDROL DOSE PACK, AND AVOIDANCE OF EARLY DEBRIDEMENT. DR. (B)(6) HAD SEEN THE PHOTOS OF THE PATIENT AND IT APPEARS THAT THE PATIENT HAS AN EMBOLIC EVENT TO THE SUPERIOR LABIAL ARTERY. ON (B)(6) 2014, (B)(6), A NURSE AT DR. (B)(6) OFFICE STATED THE PATIENT IS IMPROVING, BUT COULD NOT SAY "TO WHAT DEGREE." SHE HAD NO OTHER CASE/PATIENT INFORMATION TO PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436974 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention