BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 6105741 · Received November 16, 2016

    Report

    Report Number
    2135225-2016-00031
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 10, 2016
    Report Date
    January 3, 2017
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    UDI-DI
    M2138071M10K15
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, NECROSIS, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATING MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD FOR RADIESSE INJECTABLE IMPLANT LOT NUMBER 100083904 WAS REVIEWED. NO NONCONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR COMPLAINTS WERE NOTED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A (B)(6) PHYSICIAN AND CONCERNS A (B)(6) MALE PATIENT WHO WAS INJECTED WITH A TOTAL OF 1.5 ML OF RADIESSE INTO THE NASOLABIAL FOLDS, FOR AESTHETICAL TREATMENT, ON (B)(6) 2016. IN (B)(6) 2016, THE PATIENT EXPERIENCED HAEMATOMA AND CHANGE OF COLOUR ON THE APPLICATION SITE. HE INFORMED THE PHYSICIAN AFTER MORE THAN 24 HOURS OF STARTING SYMPTOMS. CORRECTIVE TREATMENT INCLUDED PREDNISONE, DIISOPROPYLAMINE DICHLOROACETATE (DITREI), PENTOXIFYLLINE AND ORAL SYSTEMIC ANTIBIOTIC. IN ADDITION, THE TREATING PHYSICIAN INJECTED PHYSIOLOGICAL SOLUTION TRYING TO DISSOLVE THE CALCIUM HYDROXYLAPATITE. IN THE OPINION OF THE REPORTER, THE EVENTS WERE RELATED TO RADIESSE. PHOTOGRAPHS WERE PROVIDED. FOLLOW-UP INFORMATION WAS RECEIVED ON 25-OCT-2016: THE EVENTS NECROSIS, INFLAMMATION, UNABLE TO INGEST SOLID FOOD, AND UNABLE FOR MOUTH OPENING WERE ADDED. THE PATIENT'S INITIALS WERE PROVIDED. BATCH NUMBER OF RADIESSE WAS REPORTED AS 100083904 (EXPIRY DATE IN 07/2017). ON (B)(6) 2016, 24 HOURS AFTER RADIESSE INJECTION, THE PATIENT DEVELOPED INFLAMMATION, PAIN AND ERYTHEMA AT THE INJECTION SITE. HE WAS STARTED ON STEROIDAL ANTI-INFLAMMATORY DRUGS, ANTIBIOTIC THERAPY AND PERIPHERAL VASODILATOR (PENTOXIFYLLINE). ON (B)(6) 2016, 48 HOURS AFTER THE RADIESSE INJECTION, EXTRAVASATION THROUGH ALL FACIAL BRANCH PATHWAY OCCURRED, WITH SITES OF ECCHYMOSIS THROUGH THE ANGULAR ARTERY PATHWAY. CLINICALLY, THE PATIENT REFERRED TO INCREASED PAIN IN THE APPLICATION SITE AT DIGITAL PRESSURE, WITH NORMAL TEMPERATURE AND NO EVIDENCE OF INFECTION. ORAL THERAPY WAS REINFORCED WITH TISSUE ANTI-TOXIC DRUG, AND SUBLINGUAL ANALGESIC AS NEEDED. SALINE SOLUTION WITH LIDOCAINE WAS INJECTED AND MASSAGE AT THE INJECTION SITE WAS PROVIDED FOLLOWED BY APPLICATION OF HOT WATER COMPRESS. ON (B)(6) 2016, 72 HOURS AFTER THE TREATMENT, THE PATIENT EXPERIENCED INTENSE PAIN AT DIGITAL PRESSURE, EXTENDED TO ORAL CAVITY WITH EXULCERATION ALONG THE GUMS AND MULTIPLE AGGLOMERATED ORAL SORES INTO UPPER AND LOWER LIPS. THE PATIENT WAS UNABLE TO OPEN HIS MOUTH AND INGEST FOOD. NECROSIS INCREASED IN THE ANGULAR ARTERY PATHWAY, WITHOUT SKIN TEMPERATURE CHANGES, AND PERMANENCE OF ERYTHEMA THROUGH THE COMPLETE FACIAL BRANCH PATHWAY. ANTICOAGULATION THERAPY WAS ADDED, AND NON-STEROID ANALGESIC WAS SUBSTITUTED BY A NARCOTIC ANALGESIC. THE PATIENT WAS STARTED ON A UNIQUE DOSE OF VASODILATOR (SILDENAFIL). THE TREATMENT WITH HOT WATER COMPRESSES WAS CONTINUED, ACCORDING TO THE PATIENT'S TOLERANCE, BUT MOUTHWASHES AND TOPICAL ANALGESICS WERE NOT TOLERATED BY THE PATIENT. ON (B)(6) 2016, THE NECROTIC AREA WITH EXULCERATIONS EXTENDED TO THE NOSE WING. THE PATIENT CONTINUED TO HAVE INTENSE PAIN IN ORAL CAVITY, WITH LIMITED MOUTH OPENING, UNABLE TO INGEST FOOD, AND PERSISTENT MULTIPLE AGGLOMERATED ORAL SORES AND MOUTH EXULCERATION. PREVIOUS TREATMENT WAS CONTINUED AND A SECOND DOSE OF VASODILATOR (SILDENAFIL) WAS PRESCRIBED. ON (B)(6) 2016, THE PAIN IN ORAL CAVITY CONTINUED AND THE PATIENT TOLERATED ONLY LIQUIDS, WITH IMPROVEMENT OF THE TISSUE PERFUSION, SOME NECROTIC AREAS, CRUSTS. THE THIRD AND THE LAST DOSE OF VASODILATOR (SILDENAFIL) WAS ADMINISTERED, ALONG WITH THE SAME PREVIOUS TREATMENT. ON (B)(6) 2016, THE PATIENT STARTED SOLID FOOD DIET. THE PAIN IN THE ORAL CAVITY IMPROVED BUT MULTIPLE EXULCERATED AREAS IN GUMS AND ORAL SORES PERSISTED. AT EPIDERMAL LEVEL, MULTIPLE NECROTIC AREAS WITH DIMINISHED ERYTHEMA AREAS AND WITHOUT PAIN AT DIGITAL PRESSURE WERE NOTED. CLEANING OF THE AFFECTED ZONE WAS DONE. AFTER THE CRUSTS FELL OFF, ULCERATIVE AREAS IN THE ANGULARLY ARTERY PATHWAY WERE NOTED. HYDROCOLLOID PATCH WAS APPLIED IN THE ULCERATION SITES. ON (B)(6) 2016, THE PATIENT REPORTED PAIN IMPROVEMENT IN ORAL CAVITY AND GOOD TOLERANCE TO SOLID FOODS. HE REFERRED TO A MILD PAIN. ON (B)(6) 2016, CRUSTS WERE REMOVED AGAIN AND THE CLEANING OF THE AFFECTED ZONE WAS PERFORMED. THE TREATMENT WITH TISSUE ANTI-TOXIC DRUG AND ANTICOAGULANT WAS DISCONTINUED. ANTIBIOTIC THERAPY, CORTICOSTEROIDS, PERIPHERAL VASODILATOR AND ANALGESIC WERE CONTINUED AS NEEDED. TOPICAL TREATMENT WITH PLATELET-RICH PLASMA WAS APPLIED IN ULCERATIVE AREAS AND HYDROCOLLOID PATCH WAS PLACED. ON (B)(6) 2016, THE SIZE OF THE ORAL SORES DECREASED AND THE PAIN IMPROVED. AT EPIDERMAL LEVEL, ADEQUATE TISSUE REGENERATION WITH ONLY ERYTHEMA AND SOME CRUSTS, EXULCERATION IN NASAL WING AND ATROPHIC AREAS IN NASOLABIAL FOLDS WERE NOTED. VASODILATOR AND ORAL ANTIBIOTIC WERE DISCONTINUED AND CORTICOSTEROID DOSE WAS REDUCED. FROM (B)(6) 2016, THE PATIENT WAS STILL TREATED FOR TISSUE REGENERATION, BUT HAD GOOD EVOLUTION, WITHOUT PAIN AND WITH DISCREET ERYTHEMA AND CRUSTS. THE OUTCOME OF THE EVENTS OF NECROSIS AND HEMATOMA/ECCHYMOSIS WAS REPORTED AS RESOLVING. THE OUTCOME OF THE EVENTS OF UNABLE TO INGEST SOLID FOOD AND UNABLE FOR MOUTH OPENING WERE REPORTED AS RESOLVED. IN THE OPINION OF THE REPORTER, THE EVENTS WERE OF SEVERE INTENSITY AND RELATED TO RADIESSE. PHOTOGRAPHS WERE PROVIDED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION WAS RECEIVED ON 14-DEC-2016: THE REPORTING PHYSICIAN INFORMED THAT HER PATIENT CONTINUED TO HAVE ATROPHIC SCARS, PAINFUL ERYTHEMA AND HYPERSENSITIVITY THROUGHOUT THE AFFECTED AREA. THE PATIENT DID NOT YET RECOVER AND WAS STILL IN TREATMENT. THE OUTCOME OF THE EVENTS REMAINED RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757924 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC. 100083904 M2138071M10K15

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention