BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3787229 · Received April 25, 2014

    Report

    Report Number
    2135225-2014-00029
    Event Type
    Other
    Date Received
    April 25, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 28, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR RADIESSE LOT 100067505 WAS REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECIFICATIONS FOR THIS LOT 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, THE PT WHO LIVES IN (B)(6) CALLED MERZ US TO REPORT AN ADVERSE EVENT WITH RADIESSE INJECTED TO THE NASOLABIAL FOLDS (NLF). SHE STATED THAT SHE NEEDED EXTRA THIS TIME AS HER LINES WERE DEEP. THE PT IS REPORTING PAIN CLOSE TO HER CHEEKBONE THAT STARTED ON THE DAY OF THE INJECTION. THERE WAS SWELLING AND SHE WAS TOLD TO MESSAGE. SHE DID MASSAGE. THE SWELLING CONTINUED AND HER LIP AND NOSE WERE SWOLLEN. THE NEXT DAY SHE BECAME RED FROM BETWEEN THE EYES DOWN TO THE CHIN - ALL ON THE RIGHT SIDE. SHE DEVELOPED A COLD SORE. ON THE LEFT SIDE SHE HAS THREE LITTLE WHITE BUMPS. SHE WAS PRESCRIBED ANTIBIOTICS. THE PT STATED THAT THREE WEEKS LATER THE RED COMES AND GOES. THERE IS HEAT THAT COMES AND GOES AND SHE CAN'T STAND THE HEAT. WHEN SHE BENDS DOWN SHE HAS PAIN ON THE RIGHT SIDE. THE PT STATED THAT SHE IS HAVING ANXIETY ABOUT ALL OF THIS. ON (B)(6) 2014, MERZ (B)(6) SPOKE TO THE INJECTOR, DR (B)(6) WHO STATED THAT ON (B)(6) 2014 THE PT WAS INJECTED WITH 1.5CC OF RADIESSE INTO THE NLFS. THE PT WAS SEEN FOR F/U ON (B)(6) 2014 BY DR (B)(6) AND WAS PRESCRIBED VALTREX 500 MG X 7D AND KEFLEX 500 MG QID X 1 WK. ON (B)(6) 2014, MERZ US CALLED THE PT TO ASK HOW SHE WAS. SHE STATED, "NOT SO GREAT". SHE ASKED WHERE TO GET FURTHER INFO AND SHE WAS DIRECTED TO THE RADIESSE.COM WEBSITE FOR PRODUCT AND SAFETY INFO. ON (B)(6) 2014, THE PT CALLED MERZ US TO REPORT THAT HER EYES WERE HURTING. SHE STILL HAS BURNING HEAT IN HER FACE WITH REDNESS. SHE CAN'T GO OUT IN THE SUN. SHE HAS A SINUS PROBLEM WITH DRAINAGE. SHE IS NOT ON VALTREX NOW. SHE WENT BACK TO DR (B)(6) WHO TOLD HER SHE LOOKS FINE. SHE HAS BEEN TAKING BENADRYL EVERY 4 HOURS AND HER STOMACH HURTS. DR (B)(6) TOLD HER TO TAKE ADVIL. SHE WAS PRESCRIBED PERCOSET (BY HER PSYCHOLOGIST). SHE STATED THAT SHE HAS LOST (B)(6) KGS IN ONE MONTH. ON (B)(6) 2014, MERZ (B)(6) SPOKE TO DR (B)(6). ON (B)(6) 2014, HE SAW THE PT FOR A F/U VISIT. HE PRESCRIBED GABAPENTIN 6% WITH LIDOCAINE 5% TO APPLY TOPICALLY 1-3 TIMES DAILY. HE DID NOT DOCUMENT HOW LONG SHE SHOULD BE USING THE MEDICATION. DR (B)(6), AS PER THE RECEPTIONIST, THOUGHT THE PT WAS OK AND DID NOT HAVE FURTHER CONCERNS. THERE WAS NO DOCUMENTATION IF THE PHYSICIAN WAS AWARE THE PT HAD CONSULTED WITH OTHER PHYSICIANS. THE PT HAS BEEN PRESCRIBED VALTREX AND KEFLEX AND THEN THE GABAPENTIN. ON (B)(6) 2014, THE PT CALLED MERZ US AND STATED THAT SHE HAS SEEN OTHER PHYSICIANS. SHE WAS REFERRED BACK TO THE HER RADIESSE INJECTOR. SHE HAS BEEN PRESCRIBED LORAZEPAM FOR ANXIETY. SHE STATES THAT SHE CAN BARELY CHEW FOOD ON THE RIGHT SIDE. SHE STATED THAT HER NOSE IS HURTING. SHE HAS AN APPOINTMENT WITH DR (B)(6) TONIGHT. THE PT HAD A F/U APPOINTMENT WITH DR (B)(6) ON (B)(6) 2014. NO FURTHER INFO HAS BEEN RECEIVED. IF ADD'L INFO IS RECEIVED, A F/U REPORT WILL BE SENT. NO LIDOCAINE USE WAS NOTED ON THE PT CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250473 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC 100067505

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention