BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 8312057 · Received February 6, 2019

    Report

    Report Number
    2135225-2019-00004
    Event Type
    Injury
    Date Received
    February 6, 2019
    Report Date
    February 20, 2019
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    UDI-DI
    M2138071M0K15
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: MERZ NORTH AMERICA INC. SUBMITTED AN INITIAL, 30-DAY MDR REPORT (2135225-2019-00004) TO THE FDA ON 06-FEB-2019. FOLLOW UP INFORMATION WAS RECEIVED FROM THE REPORTER AND A SECOND MDR WAS SUBMITTED TO THE FDA FOR THIS CASE ON 19-FEB-2019 UNDER 2135225-2019-00004 AND ALSO MARKED AS INITIAL. THE CASE SUBMITTED ON 19-FEB-2019 SHOULD HAVE BEEN MARKED AS FOLLOW-UP. THIS FOLLOW-UP CASE IS BEING RESUBMITTED WITH ALL FIELDS COMPLETED CORRECTLY.

    Description of Event or Problem · 0

    FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON 13-FEB-2019: THE PATIENT'S INITIALS, AGE, AND DATE OF BIRTH WERE REPORTED. CONCOMITANT MEDICATIONS REPORTED AS ZOLOFT (SERTRALINE) 60MG SIX DAYS PER WEEK, XANAX (ALPRAZOLAM) 0.5MG 1-2 NIGHTS PER WEEK, AND PERLANE INJECTED TO DIFFERENT AREAS "EXCEPT THE LATERAL ORAL COMMISSURES" ON (B)(6) 2010. ONSET DATE REPORTED AS 1-2 MONTHS POST RADIESSE INJECTIONS. THE PATIENT PRESENTED FOR RECHECK ON (B)(6) 2010 BECAUSE OF THE LUMPS. TREATMENT REPORTED AS ABOVE. THE KENALOG + 5FU INJECTIONS WERE DOSED AT ABOUT 20MG-25MG PER CC. THE NODULES WOULD SHRINK TO "ALMOST GONE" POST TREATMENT BUT RECURRED OVER THE NEXT SEVERAL MONTHS. CAUSALITY REPORTED AS RELATED.

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, NODULES ONGOING SINCE 2010, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD FOR RADIESSE DERMAL FILLER LOT 1017325 WAS REVIEWED. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR EVENTS WERE NOTED. NO NON-CONFORMANCES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A (B)(6) YEAR-OLD FEMALE PATIENT WAS INJECTED WITH 1.5CC OF RADIESSE TO THE ANTERIOR CHEEKS, NASOLABIAL FOLDS, LATERAL ORAL COMMISSURES AND PRE-JOWL/MANDIBULAR BORDER ON (B)(6) 2010. TWO MONTHS POST-TREATMENT THE PATIENT DEVELOPED A PALPABLE NODULE AT THE SUPERIOR PORTION OF THE NLF. SINCE INJECTION, THE PATIENT HAS EXPERIENCED PERSISTENT NODULES IN THE NASOLABIAL FOLDS AND THE LATERAL ORAL COMMISSURES, WHICH BECAME LARGER. TREATMENT REPORTED AS 21 KENALOG INJECTIONS TO THE NODULES, FROM (B)(6) 2010 TO (B)(6) 2019. THE KENALOG INJECTIONS WERE "AT VARIED STRENGTHS AND SOMETIMES WITH 5-FU ADDED." THE NODULES RESPONDED SOMEWHAT TO TREATMENT BUT NEVER DISAPPEARED. THEY BECAME LARGER AGAIN WITH TIME. IT WAS NOTED THAT THE PATIENT IS ALSO UNDER THE CARE OF AN ENT AND ORAL SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102508 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC. 8071M0K1 1017325 M2138071M0K15

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability