BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE

    MDR report key: 21535984 · Received March 6, 2025

    Report

    Report Number
    3013840437-2025-00028
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    March 1, 2023
    Report Date
    February 25, 2025
    Manufacturer
    MERZ NORTH AMERICA, INC (FRANKSVILLE)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD REVIEW FOR RADIESSE, LOT A00065670, WAS NORMAL, NO NONCONFORMANCE REPORTS, CORRECTIVE/PREVENTIVE ACTIONS RELATED TO THIS LOT. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND OTHER SIMILAR EVENTS WERE NOTED. ASSESSMENT BY MERZ: LOCALIZATION OF THE EVENT WAS NOT PROVIDED BUT LOCAL RELATIONSHIP CAN BE ASSUMED BASED ON THE WORDING OF THIS REPORT. ONSET DATE OF THE EVENT WAS 3 MONTHS AFTER THE INJECTION WHICH IS A LONG LATENCY BUT STILL POSSIBLE. INJECTION SITE NODULE IS EXPECTED BASED ON CURRENTLY VALID CANADIAN INSTRUCTIONS FOR USE (IFU) LEAFLET OF RADIESSE. PRODUCT PREPARATION ISSUE AND OFF LABEL USE OF DEVICE WERE CODED ONLY FOR FORMAL REASONS. INJECTION INTO THE ARM IS NO APPROVED INDICATION FOR RADIESSE IN CANADA. HOWEVER, THE REPORTED INJECTION SITE REACTION CAN OCCUR AFTER THE TREATMENT WITH RADIESSE. THEREFORE, CAUSALITY IS ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE. MERZ CAUSALITY RE-ASSESSMENT DUE TO FOLLOW-UP INFORMATION RECEIVED ON 06-OCT-2023: THE EVENT INDURATIONS WAS ADDED. THE ADDED EVENT OCCURRED IN A COMPATIBLE LOCAL RELATIONSHIP. ONSET DATE OF THE ADDED EVENT WAS WITHIN 7 MONTHS AFTER THE INJECTION WHICH IS A LONG LATENCY BUT STILL POSSIBLE. INJECTION SITE INDURATION IS EXPECTED BASED ON CURRENTLY VALID CANADIAN INSTRUCTIONS FOR USE (IFU) LEAFLET OF RADIESSE. POSSIBLE CONFOUNDING FACTORS INCLUDED REPORTER STATING THAT THE PATIENT DOING ARM TRAINING IMMEDIATELY AFTER THE RADIESSE INJECTION CAUSED THE NODULES. CAUSALITY FOR THE ADDED EVENT IS ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE. CAUSALITY FOR THE PREVIOUSLY ASSESSED EVENT REMAINS UNCHANGED AS POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE. MERZ CAUSALITY RE-ASSESSMENT DUE TO FOLLOW-UP INFORMATION RECEIVED ON 12-DEC-2023: THE OUTCOME OF THE EVENTS WAS CONSIDERED AS RESOLVING. CAUSALITY REMAINS UNCHANGED AS POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE. MERZ CAUSALITY RE-ASSESSMENT AFTER AMENDMENT WAS PERFORMED ON 16-JAN-2025: DUE TO A TECHNICAL ISSUE, LISTEDNESS AND PRODUCT EVENT MATRIX HAVE BEEN DELETED FROM THE PREVIOUS VERSION AND HAD TO BE RE-ENTERED INTO THE DATABASE. CAUSALITY FOR THE PREVIOUSLY REPORTED EVENTS REMAINS UNCHANGED AS POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE. MERZ CAUSALITY RE-ASSESSMENT AFTER FOLLOW-UP INFORMATION WAS RECEIVED ON 18-FEB-2025: THIS CASE WAS UPGRADED TO SERIOUS WITH THE SERIOUS EVENT INJECTION SITE NODULE. IN (B)(6) 2023, THE PATIENT EXPERIENCED THE ADVERSE EVENTS. PATIENT STILL REPORTED SEVERAL BUMPS. THE PATIENT WAS GOING TO SEE THE PHYSICIAN. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT SMALL BUMPS WAS CONSIDERED AS NOT RESOLVED (CHANGED FROM RESOLVING). THE OUTCOME OF THE EVENT INDURATIONS REMAINED UNCHANGED. BASED ON THE INFORMATION PROVIDED, THE EVENT OF INJECTION SITE NODULE (SERIOUS) ALREADY LASTED SINCE 2023 AND THEREFORE A PERMANENT DAMAGE FOR THIS EVENT COULD NOT BE EXCLUDED WITH CERTAINTY. HOWEVER, INFORMATION ON FURTHER CORRECTIVE TREATMENT SINCE 2023 IS PENDING. CAUSALITY FOR BOTH EVENTS (SERIOUS INJECTION SITE NODULE AND NON-SERIOUS INJECTION SITE INDURATION) REMAINS UNCHANGED AS POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE. THIS CASE IS UPGRADED TO SERIOUS WITH THE SERIOUS EVENT INJECTION SITE NODULE BECAUSE A PERMANENT DAMAGE CANNOT BE EXCLUDED.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS CASE WAS LINKED TO LSSMV CASE NUMBER (B)(4), REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CANADIAN NURSE AND CONCERNS A 61-YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE INTO THE ARMS (OFF LABEL USE OF DEVICE), ON (B)(6) 2022. SHE WAS INJECTED WITH 1 SYRINGE PER ARM. RADIESSE WAS DILUTED WITH 3.5 ML OF SODIUM CHLORIDE 0.9 % AND 1 ML OF LIDOCAINE, AT A RATIO 1:3. THERE WAS NO COMPLAIN OR INDURATION. SHE WAS INJECTED WITH RADIESSE INTO THE ARMS, ON (B)(6) 2023. SHE WAS INJECTED WITH 1 SYRINGE PER ARM. BATCH NUMBER WAS REPORTED AS A00065670 (EXPIRY DATE: 06/2024). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00065670 (EXPIRY DATE: 06/2024). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. RADIESSE WAS DILUTED WITH 3.5 ML OF SODIUM CHLORIDE 0.9 % AND 1 ML OF LIDOCAINE, AT A RATIO 1:3 (PRODUCT PREPARATION ISSUE). ON (B)(6) 2023, 90 DAYS AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED SMALL BUMPS, BUT NOTHING NOTICEABLE. THE NURSE TRIED TO DILUTE THE BUMPS WITH NORMAL SALINE. ON (B)(6) 2023, THE PATIENT WAS REINJECTED WITH RADIESSE INTO THE ARMS. SHE WAS INJECTED WITH 1 SYRINGE PER ARM. RADIESSE WAS DILUTED WITH 3.5 ML OF SODIUM CHLORIDE 0.9 % AND 1 ML OF LIDOCAINE, AT A RATIO 1:3. SHE WAS COMPLAINING THAT HER BUMPS WERE WORSE. SHE HAD 1 DILUTION TREATMENT WITH WATER AND XYLOCAINE. WEEKLY DILUTION TREATMENT WITH MASSAGE WITH GOOD FRICTION AND MASSAGE AT HOME WERE SUGGESTED. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 06-OCT-2023: THE EVENT INDURATIONS WAS ADDED. THE INDURATIONS DID NOT REDUCE IN SIZE WITH DILUTION OF WATER AND XYLOCAINE AND MASSAGE. THE NURSE DID THIS TECHNIQUE 4 TIMES AND ASKED FOR ADVICE. THE PHYSICIANS SUGGESTED TREATMENT WITH KENALOG. NURSE ALREADY DID KENALOG TREATMENT A WEEK PRIOR TO THIS REPORT. THE PATIENT REACTED VERY WELL; INDURATIONS HAVE DECREASED A LOT. THE NURSE DID SECOND TREATMENTS ON THE ARMS ACCORDING TO THE PHYSICIANS PROTOCOL: 12 SMALL INDURATIONS ON THE LEFT ARM AND 14 ON THE RIGHT ARM. A MASSAGE WITH COTTON SWAB WAS PERFORMED. SHE DID ARM TRAINING IMMEDIATELY AFTER THE RADIESSE INJECTION AND IN THE OPINION OF THE REPORTER, THIS WAS WHAT CAUSED THE NODULES. FOLLOW UP WAS SCHEDULED FOR FOLLOWING WEEK. THE OUTCOME OF THE EVENT INDURATION WAS UNKNOWN. THE OUTCOME OF THE EVENT SMALL BUMPS REMAINED UNCHANGED. FOLLOW UP INFORMATION WAS RECEIVED ON 12-DEC-2023: FOR THE SECOND TREATMENT, THE PHYSICIAN USED 1 SYRINGE EACH ARM. BATCH NUMBER WAS REPORTED AS A00065670. ON (B)(6) 2023, THE DAY PRIOR TO THIS REPORT, THE PHYSICIAN SAW THE PATIENT AND HER ARMS WERE ABOUT 50% BETTER. SHE WAS REINJECTED A TOTAL OF 1 ML PER ARM OF KENALOG SOLUTION 2.5MG/ML. SINCE SHE WAS GOING TO BE AWAY FOR 3 MONTHS SHE WANTED TO REVISIT THE SITUATION IN (B)(6). DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENTS WAS CONSIDERED AS RESOLVING (CHANGED FORM UNKNOWN). CASE CLOSURE DATED ON 08-JAN-2025: NO FURTHER INFORMATION COULD BE OBTAINED, AND THE CASE WAS CLOSED. IF ANY SIGNIFICANT NEW INFORMATION IS RECEIVED, THE CASE WILL BE REOPENED. AMENDMENT WAS PERFORMED ON 16-JAN-2025: DUE TO A TECHNICAL ISSUE, LISTEDNESS AND PRODUCT EVENT MATRIX HAVE BEEN DELETED FROM THE PREVIOUS VERSION AND HAD TO BE RE-ENTERED INTO THE DATABASE. FOLLOW-UP INFORMATION WAS RECEIVED ON 18-FEB-2025: THIS CASE WAS UPGRADED TO SERIOUS. IN (B)(6) 2023, THE PATIENT EXPERIENCED THE ADVERSE EVENTS. PATIENT STILL REPORTED SEVERAL BUMPS. THE PATIENT WAS PLANNING TO SEE THE PHYSICIAN. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT SMALL BUMPS WAS CONSIDERED AS NOT RESOLVED (CHANGED FROM RESOLVING). THE OUTCOME OF THE EVENT INDURATIONS REMAINED UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486262 RADIESSE IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC (FRANKSVILLE) A00065670

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Disability| O