BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE (+) INJECTABLE IMPLANT

    MDR report key: 18312453 · Received December 12, 2023

    Report

    Report Number
    3013840437-2023-00123
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    November 14, 2023
    Report Date
    December 12, 2023
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    UDI-DI
    M2138063M6K15
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, BLOOD VESSEL WAS OCCLUDED (VASCULAR OCCLUSION), WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. THE DEVICE HISTORY RECORD OF RADIESSE(+) INJECTABLE IMPLANT, LOT NUMBER A00079540, WAS REVIEWED. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR EVENTS WERE NOTED. NO NONCONFORMANCE REPORTS, CORRECTIVE/PREVENTIVE ACTIONS RELATED TO THIS LOT.

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A BRAZILIAN DENTIST VIA A SALES REPRESENTATIVE AND AND CONCERNS A 52-YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED SUPRAPERIOSTALY, WITH A TOTAL OF 1.5 ML OF RADIESSE(+) INTO THE JAW, ON (B)(6) 2023. BATCH NUMBER WAS REPORTED AS A00079540 (EXPIRY DATE: 09/2024). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00079540 (EXPIRY DATE: 09/2024). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. SHE WAS INJECTED WITH 0.75 PER SIDE, WITH A 27G CANNULA. THE PATIENT HAD NO AESTHETIC TREATMENTS IN THE PAST. SHE HAD NO ALLERGIES. THE PATIENTS MEDICAL HISTORY INCLUDED FIBROMYALGIA, HYPOTHYROIDISM AND HYPERTENSION. SURGICAL INTERVENTIONS AND CONCOMITANT MEDICATION WERE REPORTED AS NONE. ON (B)(6) 2023, AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED EDEMA AND ISCHEMIA ON THE LOWER LIP. SHE ALSO HAD EDEMA AND HEMATOMA ON JAW AND LIPS. THE CORRECTIVE TREATMENT INCLUDED LASER THERAPY, RADIOFREQUENCY, APPLICATION OF HYALURONIDASE AND SALINE SOLUTION, OZONE THERAPY IN THE WHOLE REGION, PREDNISONE AND DIPROSPAN. THE INTERVENTION WAS NOT NECESSARY TO PREVENT A LIFE-THREATENING CONDITION OR A PERMANENT DAMAGE. SHE WAS NOT HOSPITALIZED. THE OUTCOME OF THE EVENTS WAS UNKNOWN. IN THE OPINION OF THE REPORTER, THE EVENTS WERE NOT LIFE THREATENING, NOT PERMANENT AND DID NOT LEAD TO A NEWLY DIAGNOSED CHRONIC DISEASES. IN THE OPINION OF THE REPORTER, THE EVENT WAS NOT RELATED TO THE LOCAL INCORPORATED ANAESTHETIC. FOLLOW UP INFORMATION WAS RECEIVED ON 21-NOV-2023: THE CASE WAS UPGRADED TO SERIOUS. THE EVENT TERM ISCHEMIA WAS AMENDED TO IMPORTANT BLOOD VESSEL WAS OCCLUDED AND CODING WAS CHANGED FROM INJECTION SITE ISCHEMIA TO VASCULAR OCCLUSION. THE EVENTS EDEMA AND HEMATOMA WERE DELETED, AS THEY WERE CONSIDERED TO BE SYMPTOMS OF IMPORTANT BLOOD VESSEL WAS OCCLUDED. THE REPORTER INFORMED THAT AN IMPORTANT BLOOD VESSEL WAS OCCLUDED AND THE TECHNIQUE FAILED. THE REPORTER IMMEDIATELY STARTED AN ISCHEMIA PROTOCOL WITH MEDICATION AND OTHER TECHNIQUES TO HELP REESTABLISH BLOOD FLOW. THE PATIENT IMPROVED WITHOUT ANY RISK TO HER HEALTH. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT BLOOD VESSEL WAS OCCLUDED WAS CONSIDERED AS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289351 RADIESSE (+) INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC A00079540 M2138063M6K15

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention CONCOMITANT DRUG NOT AVAILABLE