BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2071025 · Received April 18, 2011

    Report

    Report Number
    2135225-2011-00029
    Event Type
    Other
    Date Received
    April 18, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE NOT REVIEWED, LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DR (B)(6) REPORTED INJECTING A FEMALE PT WITH RADIESSE INTO NASOLABIAL FOLDS ON (B)(6) 2011. THE PT EXPERIENCED SWELLING AND PAIN/TENDERNESS IN THE "TIP OF NOSE" AND NASOLABIAL AREA ON THE SAME DAY. NO TREATMENT WAS REPORTED. ON (B)(6) 2011, AN UPDATE WAS RECEIVED WITH ADD'L INFO. (B)(6), CONTRACT NURSE FOR (B)(6) RECEIVED INFO FROM (B)(6) IN (B)(6), WHO STATED THE PT EXPERIENCED NEUROPATHIC PAIN AND SKIN BLANCHING POST RADIESSE INJECTION. THE PT WAS ADVISED TO USE HEAT AND MASSAGE TO THE AREA AND GTN SPRAY. THE PAIN HAD WORSENED AND THE PT'S FACE IS TURNING BLACK IN THE TREATED AREA, SUGGESTING POSSIBLE NECROSIS. THE PT WAS ADVISED TO GO TO "(B)(6)". NO OTHER INFO WAS PROVIDED. ON (B)(6) 2011, AN UPDATE WAS RECEIVED WITH ADD'L INFO. THE PT WAS INJECTED WITH RADIESSE ON (B)(6) 2011, IN THE NASOLABIAL FOLDS. SHE HAD THE SAME TREATMENT LAST YEAR AND WAS FINE. AT 1 PM, HER FACE STARTED TO SWELL AND ICE PACK WAS APPLIED. BY 6PM, IT WAS ACHING. BY 6:30PM, HER FACE WAS SORE, AT 7PM, SHE WAS IN AGONY AND BRUISING. HER FACE HAD SWOLLEN LIKE A BALLOON. SHE WAS IN SEVERE PAIN. SHE SAW A PLASTIC SURGEON (NAME NOT PROVIDED) WHO IS AMAZED AT THE REACTION AND DOES NOT KNOW WHAT HAPPENED. SHE IS ON STEROIDS, PAINKILLERS AND ANTIBIOTICS (NAME, DOSES, AND FREQUENCIES WERE NOT PROVIDED). SHE COULD NOT EAT. ON (B)(6) 2011, AN UPDATE WAS RECEIVED WITH A CONFIRMATION OF INFECTION AND NOT NECROSIS. THE INFECTION WAS TREATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other (B)(4) LIDOCAINE AS A DENTAL BLOCK