BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 5097304 · Received September 23, 2015

    Report

    Report Number
    2135225-2015-00062
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 25, 2015
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT'S INJECTION SITE HAS RECOVERED. THERE IS SOME MINOR REDNESS THAT COULD BE REDUCED WITH LASER TREATMENTS. THE DEVICE HISTORY RECORD FOR THE INJECTED RADIESSE LOT WAS NOT REVIEWED AS THE LOT NUMBER WAS UNKNOWN. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A FEMALE PATIENT WAS INJECTED WITH 0.85CC OF RADIESSE TO THE NOSE (NASAL TIP-0.1ML, COLUMELLA-0.3ML, ROOT-0.45 ML) ON (B)(6) 2015. THE PATIENT EXPERIENCED SEVERE SWELLING AFTER THE INJECTION COMPARED WITH PREVIOUS TREATMENT. ON (B)(6) 2015, THE PATIENT WAS STARTED ON ANTIBIOTICS THREE TIMES DAILY PROPHYLACTICALLY BY THE INJECTOR. ON (B)(6) 2015, THE PATIENT WAS GIVEN GENTAMYCIN AND CEPHAMYCIN INTRAVENOUSLY AND ORALLY, ALONG WITH WARM COMPRESSES TO THE AREA. ON (B)(6) 2015, THE PATIENT WENT TO THE (B)(6) FOR WOUND TREATMENT. THE "CHIEF OF HOSPITAL DIAGNOSIS" SUSPECTED PATIENT HAD CELLULITIS AND PATIENT WAS HOSPITALIZED. ON (B)(6) 2015, THE PATIENT BEGAN HAVING HYPERBARIC OXYGEN THERAPY (HBOT) TWICE DAILY. THE PATIENT HAD A TOTAL OF 16 HBOT THROUGH (B)(6) 2015, WHEN SHE WAS DISCHARGED. (B)(6) 2015, THE PATIENT'S NOSE TIP STILL HAS REDNESS & THE PATIENT KEEPS DOING HBOT. ON (B)(6) 2015, THE PATIENT DID NOT GO BACK TO THE HOSPITAL FOR A FINAL EXAMINATION BUT VISITED ANOTHER PHYSICIAN WITH HER PHOTOGRAPHS. THE PHYSICIAN CONSIDERED THAT THE DIAGNOSIS SHOULD BE VASCULAR OCCLUSION, NOT CELLULITIS. THE PATIENT'S INJECTION SITE HAS RECOVERED. THERE IS SOME MINOR REDNESS THAT COULD BE REDUCED WITH LASER TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627768 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R