BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 12863133 · Received November 23, 2021

    Report

    Report Number
    3013840437-2021-00241
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 12, 2021
    Report Date
    December 3, 2021
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA, AS THE EVENT VASCULAR OBSTRUCTION (PT: VASCULAR OCCLUSION), WAS DEEMED TO MEET THE SERIOUS CRITERIA OF HOSPITALIZATION. THE DEVICE HISTORY RECORD OF RADIESSE INJECTABLE IMPLANT COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT REPORTED.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA, AS THE EVENT TINGLING (PT: INJECTION SITE PARAESTHESIA), WAS DEEMED TO MEET SERIOUS CRITERIA OF HOSPITALIZATION. THE DEVICE HISTORY RECORD OF RADIESSE INJECTABLE IMPLANT COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 0

    THIS MDR IS RELATED TO MDR 3013840437-2021-00240, REFERRING TO THE SAME PATIENT. FOLLOW-UP INFORMATION WAS RECEIVED ON 26-NOV-2021: THE EVENT VASCULAR OBSTRUCTION WAS ADDED. THE EVENTS PAIN, TINGLING AND ECCHYMOSIS WERE DELETED, THEY WERE CONSIDERED TO BY SYMPTOMS OF VASCULAR OBSTRUCTION. IT WAS CONFIRMED THAT THE PATIENT WAS HOSPITALIZED FOR AROUND 1 WEEK. CORRECTIVE TREATMENT INCLUDED ANTIBIOTICS, DECADRON, DIPYRONE, SILDENAFIL AND CLEXANE. ON (B)(6) 2021 (THE WEEK OF THIS REPORT), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND THE ADVERSE EVENT WAS REGRESSING. THE INITIAL DIAGNOSIS WAS A HEMATOMA AND LATER, IT WAS VASCULAR OBSTRUCTION. IT WAS NOT IDENTIFIED IF AN ARTERY OR VEIN WAS REACHED. THE PHYSICIAN WAS NOT SURE IF SCINTIGRAPHY WAS PERFORMED IN THE HOSPITAL. THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVING.

    Description of Event or Problem · 0

    THIS MDR IS LINKED TO MDR 3013840437-2021-00240, REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A (B)(6) HEALTH CARE PROFESSIONAL AND CONCERNS A (B)(6) FEMALE PATIENT. SHE WAS INJECTED SUPRA-PERIOSTEAL WITH A TOTAL OF 3 ML (1.5 ML, INTO EACH SIDE) OF RADIESSE DUO, INTO THE MENTO AND PRE-JOWL REGION, FOR A COLLAGEN BIO STIMULATION, ON (B)(6) 2021. RADIESSE WAS DILUTED 1:1 WITH 1 ML OF SALINE SOLUTION AND WITH 0.5 ML OF LIDOCAINE (OFF LABEL USE OF DEVICE, PRODUCT PREPARATION ISSUE). RADIESSE WAS INJECTED WITH 0.1 ML TO EACH POINT BESIDE THE MIDLINE, USING THE BOLUS TECHNIQUE. IT WAS ALSO REPORTED THAT THE PATIENT WAS INJECTED WITH A SUPRA-PERIOSTEAL BOLUSES OF 0.1 ML, INTO THE MENTO AND WITH 1.5 ML, USING A RETRO-INJECTION CANNULA, ON EACH SIDE OF THE MENTO REGION. A MIDLINE CIRCUIT WAS PERFORMED. SEVERAL PRE JOWL RE-INJECTIONS WERE MADE TO THE CENTER OF THE CHIN (ON BOTH SIDES). NEEDLE USED FOR INJECTION WAS A 22G CANNULA. THE PATIENTS MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE REPORTED AS NONE. SHE HAD NO DISPOSITION TO LYMPH DRAINAGE PROBLEMS, NO ALLERGIES, AUTOIMMUNE DISEASES, INTAKE OF INTERFERON OR OMALIZUMAB, OR SURGICAL INTERVENTIONS IN THE PAST. ON (B)(6) 2021, ONE DAY AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED ECCHYMOSIS, BUT DID NOT PRESENT ANY PAIN. ON (B)(6) 2021, THREE DAYS AFTER THE INJECTION, THE PATIENT CONTACTED THE DENTIST AND REPORTED PAIN. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN AND TINGLING IN THE MENTO REGION. CORRECTIVE TREATMENT INCLUDED ANESTHESIA WITHOUT LIDOCAINE, 1.5 ML OF HYALURONIDASE, LOCAL MASSAGE FOR 10 MINUTES, INJECTION OF A CORTICOSTEROID TRIANCIL WITH SALINE SOLUTION (DILUTED 1:1), LOCAL MASSAGE FOR ANOTHER 10 MINUTES, INJECTION OF TRIANCI AGAIN AND A LASER THERAPY WITH 3J RED LASER IN A REGION. IT WAS ALSO REPORTED THAT OZONE WERE APPLIED. THE PATIENT WAS HOSPITALIZED BECAUSE SHE DID NOT IMPROVE IN HER CONDITION AND TO UNDERGO INTRAVENOUS ANTIBIOTIC THERAPY. AT THE TIME OF THIS REPORT, THERE WAS A WORSENING OF THE ADVERSE EVENT AND THE PATIENT REMAINED HOSPITALIZED. SYSTEMIC ANTIBIOTIC FOR TREATMENT WAS PRESCRIBED FOR TREATMENT. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENTS WAS CONSIDERED AS NOT RESOLVED (ALSO REPORTED AS UNKNOWN). IN THE OPINION OF THE REPORTER, THE EVENTS WERE NOT LIFE-THREATENING, NOT PERMANENT, RELATED TO RADIESSE AND NOT TO THE INCORPORATED LOCAL ANAESTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756543 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization CONCOMITANT DRUG NOT AVAILABLE.