BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE (+) INJECTABLE IMPLANT

    MDR report key: 13207105 · Received January 10, 2022

    Report

    Report Number
    3013840437-2022-00005
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    November 2, 2021
    Report Date
    January 10, 2022
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    UDI-DI
    M2138063M0K22
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA, AS THE EVENT FULL THICKNESS NECROSIS (PT: INJECTION SITE NECROSIS), WAS DEEMED TO MEET THE SERIOUS CRITERIA OF REQUIRED MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE. THE DEVICE HISTORY RECORD OF RADIESSE(+) INJECTABLE IMPLANT, LOT NUMBER 100120662, 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 MDR IS RELATED TO MDR 3013840437-2021-00236 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US NURSE AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE(+), INTO THE NOSE (OFF LABEL USE OF DEVICE), AS A LIQUID RHINOPLASTY (AS BELIEVED BY THE REPORTER). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS 100120662 (EXPIRY DATE 05/2021). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED A POSSIBLE VASCULAR OCCLUSION. HEAT WAS APPLIED. THE PATIENT TOOK ASPIRIN AND WAS MONITORED. THE REPORTER FOLLOWED THE FLOW CHART FROM A PAPER AND THEY WERE ABLE TO RESTORE BLOOD FLOW IN THE MODELED AREA. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS RESOLVING. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2022: THE EVENT TERM WAS AMENDED FROM POSSIBLE VASCULAR OCCLUSION TO VASCULAR OCCLUSION, AND THE EVENT CODING REMAINED UNCHANGED. THE EVENT FULL THICKNESS NECROSIS WAS ADDED. THE PATIENTS INITIALS, GENDER (MALE), AGE AND WEIGHT ((B)(6) KG) WERE PROVIDED. HE WAS (B)(6) YEARS OLD AT THE TIME OF THE EVENTS. THE PATIENT WAS INJECTED WITH A TOTAL OF 1 ML OF RADIESSE(+), IN (B)(6) 2021. APPROXIMATELY 3 YEARS AFTER HIS LAST RHINOPLASTY, PERFORMED BY THE REPORTING PHYSICIAN, THE PATIENT COMPLAINED OF SOME RESIDUAL ASYMMETRY. THE PHYSICIAN FELT THAT A 4TH RHINOPLASTY WAS TOO RISKY AND UNWANTED. AT THE TIME, THEY FELT THAT THEY WERE GOING TO BE ABLE TO ACHIEVE BETTER SYMMETRY WITH SOME RADIESSE INJECTED ALONG THE RIGHT LATERAL, MORE CONCAVE, SIDE OF HIS NOSE. THE PATIENTS PAST MEDICAL HISTORY INCLUDED A HISTORY OF SMOKING AND 3 RHINOPLASTY SURGERIES. CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. ON (B)(6) 2021, WITHIN 24 HOURS AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED A VASCULAR OCCLUSION WITH IMPENDING SKIN LOSS. HE WAS TREATED WITH A HIGH DOSE OF ASPIRIN, CIALIS 20MG ONCE A DAY, TOPICAL NITRO PASTE, WARM COMPRESSES AND SEVERAL HYPERBARIC OXYGEN TREATMENTS (REPORTED AS HBO2). OVER THE COURSE OF THE NEXT FEW WEEKS, HE HAD 2 SPOTS ALONG THE LATERAL ASPECT OF THE NOSE, WITH FULL THICKNESS NECROSIS. MOST OF HIS TIP AND RIGHT SIDE OF HIS NOSE SUFFERED PARTIAL SKIN THICKNESS LOSS AND SIGNS OF VASCULAR COMPROMISE. EVENTUALLY, AFTER 4-5 WEEKS, THE MICROCIRCULATION IMPROVED AND THE SKIN AND WOUNDS BEGAN TO HEAL. ABOUT 8 WEEKS OUT, THE PHYSICIAN SAW THE PATIENT AND THE WOUNDS WERE CLOSED, THE SCARS WERE MINIMAL, AND THE COLOUR OF HIS NOSE WAS ALMOST NORMAL. NO RELEVANT LABORATORY TEST WAS PERFORMED. THE OUTCOME OF THE EVENT VASCULAR OCCLUSION REMAINED UNCHANGED. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT FULL THICKNESS NECROSIS WAS CONSIDERED AS RESOLVING. IN THE OPINION OF THE REPORTER, TREATMENT WAS NECESSARY TO PREVENT PERMANENT DAMAGE. AS REPORTED, THE REPORTER DID NOT BELIEVE THAT THE EVENT WAS DIRECTLY RELATED TO THE USE OF RADIESSE(+) SPECIFICALLY AND BELIEVED THAT AN INJECTION OF ANY FILLER TO THIS AREA WAS ABLE TO CAUSE THIS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637320 RADIESSE (+) INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC 100120662 M2138063M0K22

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention CONCOMITANT DRUG NOT AVAILABLE.