BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 6641558 · Received June 14, 2017

    Report

    Report Number
    2135225-2017-00012
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    May 17, 2017
    Report Date
    June 14, 2017
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    PKY
    UDI-DI
    M2138069M4K15
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, CELLULITIS, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATING 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 INJECTABLE IMPLANT LOT NUMBER 100082548 WAS REVIEWED. NO NONCONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR COMPLAINTS WERE NOTED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CANADIAN NURSE AND CONCERNS A (B)(6) FEMALE PATIENT (HERSELF) WHO WAS INJECTED WITH A TOTAL OF 0.8 ML OF RADIESSE INTO RIGHT HAND FOR HAND REJUVENATION ON (B)(6) 2017. BATCH NUMBER WAS REPORTED AS 100082548 (EXPIRY DATE IN MAY-2017). RADIESSE WAS MIXED WITH 0.5 ML OF 1% XYLOCAINE. THE PATIENT HAD PREVIOUS TOXIN AND FILLER TREATMENTS FOR THE LAST 12 YEARS WITHOUT ANY REACTION BEFORE. THIS WAS THE PATIENT'S FIRST TIME RECEIVING RADIESSE AS WELL AS HER FIRST TIME RECEIVING TREATMENT IN HER HAND. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPOTHYROIDISM AND FUNGAL/BACTERIAL INFECTION IN HER RIGHT THUMB IN THE LAST 6 MONTHS. THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED MARVELON AND SYNTHROID. THE PATIENT'S PAST MEDICATIONS INCLUDED ANTIBIOTICS. ON (B)(6) 2017, 12 HOURS AFTER RADIESSE INJECTION, THE PATIENT EXPERIENCED SWELLING, REDNESS AND HEAT IN THE RIGHT HAND. BY (B)(6) 2017, THE PATIENT'S HAND WAS VISIBLY SWOLLEN AND THE PHYSICIAN AT HER CLINIC RECOMMENDED HER TO GO TO HOSPITAL EMERGENCY DEPARTMENT. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2017, WHERE SHE RECEIVED ORAL ANTIBIOTICS. THE EMERGENCY PHYSICIAN EXAMINED THE PATIENT'S HAND AND NOTED THAT THE INFECTION SPREAD TO THE PATIENT'S ELBOW (REDNESS, SWELLING AND HEAT UP TO THE ELBOW) AND THAT THE PATIENT'S RIGHT AXILLARY GLAND WAS SWOLLEN. THE PATIENT WAS PRESCRIBED 1000 MG OF KEFLEX EVERY 6 HOURS FOR THE FIRST 48 HOURS, FOLLOWED BY 1000 MG KEFLEX TWICE A DAY UNTIL MEDICATION WAS FINISHED. ON (B)(6) 2017, THE PATIENT REPORTED THAT SHE WAS STABLE, BUT SHE DID NOT NOTICE ANY IMPROVEMENT YET, THEREFORE THE OUTCOME OF THE EVENT WAS CONSIDERED AS NOT RESOLVED. IN THE OPINION OF THE REPORTER, THE EVENT WAS OF SEVERE INTENSITY, NOT PERMANENT, NOR LIFE-THREATENING AND RELATED TO RADIESSE. FOLLOW-UP INFORMATION WAS RECEIVED ON 24-MAY-2017: THE EVENT WAS CHANGED FROM INFECTION TO CELLULITIS. THE NEEDLE USED FOR INJECTION WAS REPORTED AS 25G, 1.5 INCH (100093236) CANNULA. PREVIOUS INFORMATION ALREADY INCLUDED THAT THE PHYSICIAN BELIEVED THAT THE BACTERIA FROM THE THUMB INFECTION WERE STILL PRESENT IN A DORMANT FORM AND POSSIBLY REACTIVATED BY THE RADIESSE INJECTION. ON (B)(6) 2017, THE PATIENT WENT FOR HER FOLLOW-UP APPOINTMENT AT THE HOSPITAL, AND THE PHYSICIAN WAS PLEASED WITH HER PROGRESS. THE PATIENT WAS NOT TREATED WITH IV ANTIBIOTICS BY HER PHYSICIAN. THE MORE ACCURATE DIAGNOSIS WAS CELLULITIS THAT COULD HAVE SPREAD TO A MORE SERIOUS CONDITION. THE PHYSICIAN COMMENTED THAT THE TIMELY INTERVENTION PROVIDED ON (B)(6) 2017, PREVENTED THE WORSENING OF THE PATIENT'S CONDITION, AND ADDED THAT IF THEY DID NOT TREAT HER ON (B)(6) 2017, BY THE NEXT DAY THERE WAS A POSSIBILITY THE PATIENT HAD TO BE HOSPITALIZED FOR 2 DAYS DUE TO THE SPREAD OF THE INFECTION. AS PER REPORTER, THE PATIENT WENT TO THE HOSPITAL FOR LESS THAN 24 HOURS. THE PATIENT HAD LEFTOVER MEDICATION THAT SHE HAD TO FINISH COMPLETELY. THE PATIENT REPORTED SHE FELT MUCH BETTER AND INFORMED THERE WAS SLIGHT REDNESS REMAINED ON THE HAND (1 ON A SCALE OF 4). DUE TO THE PROVIDED INFORMATION, THE OUTCOME FOR THE EVENT WAS CONSIDERED AS RESOLVING. FOLLOW-UP INFORMATION WAS RECEIVED ON 07-JUN-2017: ON (B)(6) 2017, ALL THE REDNESS RESOLVED. IT WAS CONFIRMED THAT THE PATIENT COMPLETELY RECOVERED AND THAT SHE WAS SATISFIED WITH HER TREATMENT. THE OUTCOME OF THE EVENT WAS THEREFORE CHANGED FROM RESOLVING TO RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422555 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE IN THE HANDS PKY MERZ NORTH AMERICA, INC. 100082548 M2138069M4K15

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention MARVELON (ETHINYLESTRADIOL, DESOGESTREL)| SYNTHROID (LEVOTHYROXINE SODIUM)| XYLOCAINE