BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3445221 · Received October 24, 2013

    Report

    Report Number
    2135225-2013-00149
    Event Type
    Other
    Date Received
    October 24, 2013
    Report Date
    October 17, 2013
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS INJECTED OVER A MONTH AGO WITH RADIESSE INTO THE TEMPLES, MIDFACE, LOWER FACE. HE RETURNED LAST WEEK WITH SIGNIFICANT SWELLING, FESTOONING UNDER THE EYES. THIS IMPROVED WITH ANTIHISTAMINES AND MASSAGE. EXAM OF THE AREA WAS HARD TO THE TOUCH IN THE CENTER CHEEKS. NOW THE PATIENT IS COMPLAINING THAT HIS ENTIRE FACE IS SWELLING. DR (B)(6) SPOKE WITH A MERZ NORTH AMERICA, INC NURSE, (B)(4). THEY DISCUSSED THIS MALE PATIENT THAT DR (B)(6) INJECTED APPROXIMATELY ONE MONTH AGO THAT WAS EXPERIENCING INDURATION IN THE MIDFACE AND COMPLAINED OF SWELLING OVER THE ENTIRE FACE. THE PATIENT COMPLAINED OF SWELLING OVER THE ENTIRE FACE. THE PATIENT COMPLAINED OF FESTOONING 3 WEEKS POST INJECTION IN THE BILATERAL INFRAORBITAL AREA AND DR (B)(6) TREATED WITH AN ANTIHISTAMINE AND TOPICAL STEROID. AT THAT TIME, THE PATIENT REFUSED THE OFFER OF AN ORAL STEROID. DR (B)(6) ALSO TREATED THE PATIENT TWICE WITH A MILD HEAT TREATMENT TO RELIEVE THE FESTOONING. THE PATIENT HAD A SATISFACTORY RESULT TO THIS TREATMENT. NOW, ONE MONTH POST TREATMENT, THE PATIENT REPORTS THAT HIS MIDFACE STILL FEELS "HARD" AND SWELLING IS ENCOMPASSING AREAS OF THE FACE WHERE HE WAS NOT TREATED WITH RADIESSE. (B)(4) ASKED DR (B)(6) IF SHE FELT THAT THIS WAS INFECTIOUS IN NATURE AND SHE STATED SHE DID NOT; HOWEVER, SHE WAS GOING TO TREAT WITH AN ANTIBIOTIC. WE ALSO DISCUSSED THAT THIS COULD BE A POSSIBLE DELAYED HYPERSENSITIVITY REACTION. WE DISCUSSED THE POSSIBILITY OF A REACTION TO THE CMC GEL CARRIER. (B)(4) SHARED TREATMENT MODALITIES MOST OFTEN USED BY HCPS SUCH AS: COOL COMPRESS, HEAD ELEVATION, ORAL/IM/IV CORTICOSTEROIDS, ANTIHISTAMINE AND/OR H2 BLOCKER SUCH AS ZANTAC, AND/OR SINGULAIR. DR (B)(6) IS VERY CONCERNED ABOUT THIS PATIENT AS SHE HAS BEEN INJECTING FOR MANY YEARS AND HAS NEVER SEEN A REACTION LIKE THIS PATIENT IS EXPERIENCING. A MERZ NORTH AMERICA, INC CONTRACTED PHYSICIAN. DR (B)(4) EMAILED DR (B)(6): I AGREE WITH (B)(4) THAT THIS MAY REPRESENT AN INFLAMMATORY REACTION TO THE CARRIER GEL. THE FESTOONS ALONE ARE TYPICALLY DUE TO PRODUCT COMPRESSING LYMPHATICS POSTERIOR TO THE ORBITAL SEPTUM. WITH THE COMBINATION OF SWELLING AND FIRMNESS THE ENTIRE PICTURE MAY BE DUE TO AN INFLAMMATORY REACTION. I AGREE WITH YOUR TREATMENT TO DATE INCLUDING ORAL STEROIDS AND H1 AND H2 BLOCKERS. AS WE DISCUSSED, IF YOU PLAN TO TREAT WITH ANTIBIOTICS THE CURRENT RECOMMENDATION IS LONG TERM (6 WEEKS PLUS) BIAXIN 500 MG BID. SINCE YOU HAVE ALREADY CALLED IN THE SEPTRA DS, I THINK IT IS REASONABLE TO TREAT WITH THAT AND THE MEDROL AND ONLY CONSIDER THE BLAXIN IF HE DOESN'T RESPOND OR OF HE INITIALLY RESPONDS BUT THEN REBOUNDS. AS I MENTIONED, THERE HAVE BEEN NO DOCUMENTED CASES OF COLONOZATION TYPE INFECTIONS WITH RADIESSE BUT ANECDOTAL EVIDENCE HAS SHOWN SOME BENEFIT. ON (B)(6) 2013 DR (B)(6) STATED THAT THE PATIENT DID WELL AFTER STEROIDS. SHE GAVE THE PATIENT ANTIBIOTICS, CIPRO FOR 10 DAYS FOR BOTH PROPHYLACTIC AND A SUSPECTED INFECTION. THIS COULD BE AN INFECTION OR A HYPERSENSITIVITY REACTION. DURING THIS CALL SHE REPORTED THAT SHE HAD ANOTHER CASE OF PATIENT REACTION. (B)(4) WAS OPENED. THUS THIS CASE IS REPORTABLE TO THE FDA WITH AN AWARE DATE OF (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546175 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MIXED WITH AN UNKNOWN AMOUNT OF LIDOCAINE| TOPICAL ANESTHETIC