BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3037692 · Received March 27, 2013

    Report

    Report Number
    2135225-2013-00034
    Event Type
    Other
    Date Received
    March 27, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MERZ AESTHETICS PA EXPLAINED IN DETAIL TO HER THAT SHE HAS SEEN CASES SIMILAR TO THIS AND IS CONSISTENT WITH A VASCULAR EVENT. BASED ON HER INJECTION PATTERN, ONSET AND PROGRESSION OF SYMPTOMS; THIS IS CONSISTENT WITH AN INFRAORBITAL ARTERIAL OCCLUSION WHICH ALSO EXPLAINS THE DISTRIBUTION OF NUMBNESS. EITHER SOFT TISSUE SWELLING OR PRODUCT COMPRESSING THE NERVE IS THE ETIOLOGY OF THE PARESTHESIA WHICH TYPICALLY RESOLVES ALONG WITH THE SWELLING. I SUGGESTED SHE INSPECT THE ORAL MUCOSA AND GUM LINE FOR EROSION OR IRRITATION WHICH IS SOMETIMES SEEN IN THESE CASES. ON 03/01/2013 THE MERZ AESTHETICS PA SPOKE WITH (B)(6) ABOUT THE PATIENT. (B)(6) ASKED HER MEDICAL DIRECTOR WHO IS AN ER PHYSICIAN TO CALL THE MERZ AESTHETICS PA TO DISCUSS THIS CASE. HE IS CERTAIN SHE HAS BELL'S PALSY. THE MERZ AESTHETICS PA REVIEWED DETAILS OF THIS CASE WITH (B)(6) INCLUDING ETIOLOGY AND FACIAL ANATOMY OF THE INFRAORBITAL REGION. BOLUS SIZE SHOULD NOT EXCEED 0.2 CC AT ANY GIVEN LOCATION OVER BONE. KEEPING INJECTIONS INFERIOR AND LATERAL TO 10 FORAMEN AS WELL AS KEEPING BEVEL LATERAL IN THE MEDICAL CHEEK COMPARTMENT TO AVOID COMPRESSING OR INJECTING NEAR THE NERVE AND VESSELS WAS STRESSED. SHE DID NOT KNOW ABOUT THE 0.2 CC BOLUS AND ROUTINELY PLACES A 0.3 CC BOLUS BUT WILL CHANGE THAT FROM HERE ON OUT. THE MERZ AESTHETICS PA ALSO SHARED BASED ON OTHER CASE REPORTS LIKE THIS SWELLING CAN BE REDUCED WITH A MEDROL DOSE PAK WHICH MAY HASTEN THE RESOLVE OF THE NUMBNESS. THERE MAY BE PRODUCT SITTING ON THE NERVE VS STS (SOFT TISSUE SWELLING) OR COMBINATION OF BOTH AND THE NEED TO RELIEVE THE COMPRESSION WAS REVIEWED. SHE WILL CONSIDER THAT WHEN SHE SEES HER LATER TODAY. THE PATIENT REPORTS FEELING BETTER SINCE YESTERDAY ((B)(6) 2013) BUT DOES HAVE SOME GUM IRRITATION. SHE WILL EXAMINE HER CLOSELY TODAY AND SEND ME AN UPDATED PHOTO. DR. (B)(6), HER MEDICAL DIRECTOR WAS GIVEN CONTACT INFORMATION FOR DR. (B)(4), MERZ AESTHETICS MEDICAL DIRECTOR AS HE WOULD BENEFIT FROM DISCUSSION ABOUT THIS CASE. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PT WAS INJECTED WITH A 1.5CC RADIESSE SYRINGE; 1.3CC WAS INJECTED INTO THE CHEEK AREA AND 0.1CC WAS INJECTED INTO THE UPPER NLF. WITHIN AN HOUR, THE PT COULD NOT LIFT HER UPPER LIP AND THE LEFT SIDE OF HER FACE APPEARED TO HAVE DROPPED. ON SUNDAY THE PT STARTED TO DEVELOP SOME REDNESS AND WAS CONCERNED WITH "SOMETHING" BEING WRONG. SHE IS CURRENTLY GETTING A CT SCAN TO RULE OUT AN ABCESS, HAS BEEN DIAGNOSED WITH A BELLS PALSY AND CELLULITIS. THERE IS NO RESULT YET FROM THE CT SCAN WHICH MAKES (B)(6) THINK THAT THERE ARE NO ISSUES (IT WAS NOT RUSHED). AFTER THE RADIESSE INJECTION, THE DR AT HER FACILITY TOLD THE PT IT WAS BELLS PALSY. THEN THE PT WENT TO HER DR AND WAS ALSO TOLD SHE HAD CELLULITIS. THE DR IS TRYING TO SEE IF THE PT HAS AN ABSCESS. THE DR PRESCRIBED CLINDAMYCIN PO, DOSE AND DURATION UNK. (B)(6) WAS ASKED IF THE PT HAD ANY RECENT DENTAL WORK OR A RECENT INFECTION (VIRAL OR BACTERIAL). (B)(6) STATED THAT SHE WOULD FIND OUT. (B)(6) STATED THAT THE PT ASKED HER TO CALL THE COMPANY. (B)(6) IS WONDERING IF PRESSURE ON A NERVE CAN MIMIC BELL'S PALSY. HALF OF THE PT'S FACE FELT PARALYZED. NOW THE LIPS AREN'T QUITE RIGHT. THE LIP IS STILL SWOLLEN. INITIALLY THERE WAS NO MOVEMENT. ON (B)(6) 2013, (B)(6) SPOKE TO A MERZ AESTHETICS, PHYSICIAN ASSISTANT (PA); (B)(6) INDICATED SHE WAS INJECTING THE MID FACE VIA SERIAL BOLUS TECHNIQUE OVER BONE. THREE INJECTIONS STARTING AT THE MID-PUPIL WORKING LATERAL WITH BOLUSES 0.3, 0.2 AND 0.2 WAS INJECTED INTO THE MID CHEEK. THERE WAS NO BLANCHING OR PAIN NOTED UPON INJECTION. WITHIN 40 MINS, HER ENTIRE LEFT SIDE OF FACE INCLUDING LIP DROOPED. THE PT WAS STILL IN HER OFFICE WHEN THIS OCCURRED. SHE HAD HER MEDICAL DIRECTOR LOOK AT HER AND SHE WAS TOLD SHE HAD BELL'S PALSY. (B)(6) SENT HER HOME THINKING THIS WAS RELATED TO THE LIDOCAINE AND EXPECTED IMPROVEMENT OVER TIME. SUBSEQUENTLY SHE WORSENED AND SOUGHT CARE BY TWO OTHER PHYSICIANS WHO REPORTEDLY PERFORM DERMAL FILLERS. SHE WAS AGAIN TOLD SHE HAD BELL'S PALSY AND CELLULITIS AND WAS STARTED ON CLINDAMYCIN. (B)(6) THINKS THIS MAY BE A VASCULAR ISSUE. I ASKED HER TO SEND ME PHOTOS SINCE SOMETHING DIDN'T SEEM TO BE ADDING UP. I SHARED THAT I THINK THIS SOUNDS MORE VASCULAR TO ME AS WELL. SHE DESCRIBED THE MOTTLED AND SWOLLEN APPEARANCE OF HER LEFT CHEEK TO ME. ONCE I REVIEWED PHOTOS, I CONTACTED HER VIA E-MAIL AND STATED THIS CERTAINLY APPEARS VASCULAR BASED ON THE APPEARANCE AND DISTRIBUTION OF THE MOTTLED SKIN DISCOLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127310 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 8071M0K1 100060155

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention