BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 4224024 · Received October 30, 2014

    Report

    Report Number
    2135225-2014-00087
    Event Type
    Other
    Date Received
    October 30, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MERZ NORTH AMERICA INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG # 8071M0K1, LOT # 10006324 (EXP DATE 03/01/2015), MFR DATE: 03/2013. THE DEVICE HISTORY RECORDS FOR THE REPORTED RADIESSE LOTS WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, (B)(6) CALLED MERZ TO REPORT THIS EVENT: THE PT WAS INJECTED ON (B)(6) 2014 AND LOVED HER RESULTS. TWO WEEKS AGO, THE PT BECAME DEHYDRATED AND WAS GIVEN 5L OF FLUID AT THE ER. HER TEMPERATURE WAS 102 DEGREES F. SINCE THE DEHYDRATION OF THE PT HAS HAD VISIBLE SWELLING OF THE INJECTION SITED IN THE PRE-JOWEL SULCUS (PSJ). LAST WEEK THE PT'S PHYSICIAN PRESCRIBED AN ANTIBIOTIC (PROPHYLACTIC) AND PREDNISONE. A BLOOD CULTURE WAS TAKEN, RESULTS NEGATIVE, A CHEST X-RAY WAS NEGATIVE. THE NURSE INJECTOR, HOLY BELIEVES THAT THE DEHYDRATION IS RELATED TO A VIRUS THAT THE PT HAS. (B)(6) DOESN'T THINK THAT THIS IS RELATED TO THE RADIESSE AS THE PT DID NOT HAVE ANYTHING HAPPEN UNTIL 2 WEEKS AGO. THE PT CAME IN TO SEE (B)(6) ON (B)(6) 2014. THE PT WILL SEE HER DOCTOR ON ((B)(6) 2014). ON (B)(6) 2014 (B)(6) SPOKE TO A MERZ NURSE. THE PT WAS INJECTED WITH THREE 1.5CC SYRINGES OF RADIESSE ON (B)(6) 2014 TO THE MIDFACE, LATERAL CHEEK, AND PJS. THE PT HAD A GOOD OUTCOME WITHOUT ANY ADVERSE EVENTS. THE PT RECENTLY BECAME ILL WITH A RESPIRATORY ISSUE, BECAME FEBRILE (102F), NO VOMITING OR DIARRHEA NOTED. THE PT TOLD (B)(6) THAT SHE WAS IN THE ER THREE DIFFERENT TIMES AND AT ONE POINT RECEIVED 5L OF FLUID FOR DEHYDRATION. THE PT WAS NOT ADMITTED TO THE HOSPITAL. THE PT IS CURRENTLY SEEING A PHYSICIAN FOR HER CURRENT ILLNESS WHICH IS AS YET UNDIAGNOSED. THE PT HAD A NEGATIVE BLOOD CULTURE AND NEGATIVE CHEST X-RAY. THE PT TOLD (B)(6) THAT SINCE SHE RECEIVED THE 5F OF FLUIDS (2 WEEKS AGO) SHE HAS HAD SWELLING IN THE PJS WHERE SHE WAS INJECTED. (B)(6) STATES THERE IS NO ERYTHEMA PRESENT IN THE AREA AND THAT THE AREA FELT WARM; HOWEVER, HER ENTIRE FACE WAS WARM AND (B)(6) WAS UNSURE IF SHE WAS FEBRILE AT THE TIME OF THE VISIT. (B)(6) DID NOT EVALUATE THE PT FOR LYMPH NODE SWELLING. CURRENTLY, THE PT HAS BEEN PRESCRIBED AN ANTIBIOTIC AND PREDNISONE BY HER TREATING PHYSICIAN FOR HER CURRENT ILLNESS. THE MERZ NURSE AND (B)(6) DISCUSSED THAT IT IS HIGHLY UNLIKELY THAT SWELLING FROM RDF WOULD BEGIN 3.5 MONTHS POST INJECTION. SHE DOES NOT HAVE ANY SWELLING IN THE MIDFACE OR LATERAL CHEEK WHERE SHE WAS ALSO INJECTED WITH RADIESSE. (B)(6) STATED THE PT WILL SEE HER TREATING PHYSICIAN ON (B)(6) 2014 FOR FURTHER EVALUATION REGARDING HER ILLNESS. IN THE MEANTIME (B)(6) STATED THAT SHE IS GOING TO HAVE THE PT APPLY WARM COMPRESSES AND KEEP HER HEAD EVALUATED WHILE SLEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695953 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA INC 100072677

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R