BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE (+) INJECTABLE IMPLANT

    MDR report key: 12775085 · Received November 8, 2021

    Report

    Report Number
    3013840437-2021-00235
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    October 16, 2021
    Report Date
    November 8, 2021
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    UDI-DI
    M2138063M0K22
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, VASCULAR COMPRESSION (PT: VASCULAR COMPRESSION) WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATED 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 (+) LOT NUMBER A00017660 WAS REVIEWED. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO OTHER SIMILAR EVENTS WERE NOTED. NO NONCONFORMANCES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    THIS CASE WAS LINKED TO (B)(4), REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE. AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED VASCULAR COMPRESSION. THE REPORTER WANTED TO KNOW ABOUT DISSOLVING OR DISPERSING RADIESSE. THE REPORTER HEARD ABOUT SODIUM THIOSULFATE OR SODIUM BICARBONATE WERE USED TO HELP. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 29-OCT-2021: THIS CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE(+). THE LINKING SENTENCE WAS ADDED TO THE TOP OF THE NARRATIVE. THE PATIENTS INITIALS, AGE, DATE OF BIRTH AND GENDER WERE PROVIDED. THE PATIENT WAS A (B)(6) FEMALE PATIENT. SHE WAS INJECTED WITH A TOTAL OF 1.5 ML OF RADIESSE(+), INTO THE BILATERAL (REPORTED AS B) NASOLABIAL FOLDS, NASAL TRIANGLES AND BILATERAL MALAR CHEEKS (OFF LABEL USE OF DEVICE), ON (B)(6) 2021. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+), WAS CONFIRMED AS A00017660 (EXPIRY DATE 05/2023). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. SHE WAS CONCOMITANTLY INJECTED WITH A TOTAL OF 1 ML OF JUVEDERM ULTRA, INTO THE UPPER AND LOWER LIPS, ON (B)(6) 2021. THE PATIENT WAS PREVIOUSLY INJECTED WITH RADIESSE, INTO THE SAME AREA, YEARLY, FOR MANY YEARS, WITHOUT INCIDENT. ON (B)(6) 2021, 24 HOURS AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED VASCULAR COMPRESSION WITH ISCHEMIA TO THE CENTRAL FACE, AND PUSTULE FORMATION EVOLVING INTO DRY CRUSTS WITH UNDERLYING SUPERFICIAL EROSIONS ALONG THE RIGHT NASAL ALAR CREASE, INCLUDING BELOW THE NOSTRIL. CORRECTIVE TREATMENT INCLUDED HYALURONIDASE, ASPIRIN, A MEDROL DOSEPAK, BACTRIM AND MUPIROCIN. AT THE TIME OF THIS REPORT, THE PATIENT HAD ONGOING TREATMENT. VASCULAR COMPRESSION WITH ISCHEMIA WAS RESOLVED, AND THE PUSTULE FORMATION EVOLVING INTO DRY CRUSTS WITH UNDERLYING SUPERFICIAL EROSIONS WAS STILL HEALING. THE PATIENTS LABORATORY TEST INCLUDED A VIRAL CULTURE, AND THE RESULTS WERE PENDING. THE REPORTER WAS NOT YET ABLE TO DETERMINE IF THE EVENT WAS GOING TO RESULT IN MINOR SCARRING. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS RESOLVING, AND WAS THEREFORE CHANGED FROM UNKNOWN TO RESOLVING. IN THE OPINION OF THE REPORTER, TREATMENT WAS NECESSARY TO PREVENT PERMANENT DAMAGE AND THE EVENT WAS RELATED TO RADIESSE(+). THE REPORTER SUSPECTED DELAYED VASCULAR COMPRESSION (AS OPPOSED TO INTRAVASCULAR OCCLUSION), WHICH WAS POSSIBLY PRECIPITATED BY THE CONCOMITANT LIP FILLER WITH JUVEDERM AND DELAYED HYDROPHILIC PROPERTIES OF JUVEDERM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674142 RADIESSE (+) INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC A00017660 M2138063M0K22

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention JUVEDERM ULTRA