BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3644494 · Received December 10, 2013

    Report

    Report Number
    2135225-2013-00157
    Event Type
    Other
    Date Received
    December 10, 2013
    Date of Event
    November 11, 2013
    Report Date
    November 12, 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). THE DEVICE HISTORY RECORDS FOR THE RADIESSE LOT COULD NOT BE REVIEWED AS THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT WAS INJECTED WITH RADIESSE ON SATURDAY, (B)(6) 2013 IN THE NLF'S BY DR (B)(6). ON (B)(6) 2013 DR (B)(6) SPOKE TO A MERZ NORTH AMERICA PHYSICIAN ASSISTANT. THE PHYSICIAN STATED THAT HE STAYED IN THE INFERIOR ASPECT BILATERALLY AND USED APPROXIMATELY 0.6-0.7CC'S/NLF. THE AREA OF INVOLVEMENT IS THE RIGHT UPPER NLF EXTENDING INTO THE UPPER LIP. THE PHYSICIAN DOES NOT RECALL THE PATIENT HAVING ANY ANATOMY ALTERING PROCEDURES BETWEEN HER LAST INJECTION. HE REPORTS A SUBDERMAL THREADING TECHNIQUE. HE REPORTS NO PROBLEMS DURING OR AFTER INJECTION, BLANCHING AND NO INCREASED PAIN DURING OR AFTER INJECTIONS. THE PATIENT CALLED THE PHYSICIAN ON MONDAY, (B)(6) 2013 REPORTING SYMPTOMS OF PAIN AFTER INJECTION AND DISCOLORATION. THE PHYSICIAN SAW THE PATIENT ON (B)(6) 2013 AND SUSPECTED A POTENTIAL VASCULAR OCCLUSION. DR (B)(6) PRESCRIBED DOXYCYCLINE 100MG BID, MEDROL DOSE PAK, MOIST HEAT, ASPIRIN, NITROPASTE, AND MASSAGE. ON (B)(6) 2013 DR (B)(6) SPOKE TO A MERZ NORTH AMERICA CONTRACTED PHYSICIAN, DR (B)(6). DR (B)(6) REVIEWED THE CASE REPORT AND PHOTOS. THE PATIENT HAD A CASE OF VASCULAR COMPROMISE IN THE RIGHT NASOLABIAL FOLD AND UPPER LIP. AT THE TIME OF PRESENTATION SHE HAD DEVELOPED DUSKY ERYTHEMA AND PUSTULES WITH THREATENING SKIN BREAKDOWN. DR (B)(6) HAD ALREADY APPROPRIATELY TREATED HER WITH WARM COMPRESSES, STEROIDS, AND ORAL ANTIBIOTICS. DR (B)(6) RECOMMENDED THAT THE PATIENT START VINEGAR SOAKS AND OCCLUSIVE OINTMENT EVERY TWO HOURS AND CONSIDER ADDING TNS (GROWTH FACTOR SERUM). ON (B)(6) 2013, DR (B)(6) RECEIVED PHOTOS OF THE PATIENT AND SHE WAS IMPROVING NICELY AS EXPECTED. THE ERYTHEMA WAS DECREASED AND THERE WAS NO SKIN BREAKDOWN BUT CONTINUED SUPERFICIAL PUSTULES. DR (B)(6) RECOMMENDED CONTINUING THE SOAKS AND OINTMENT AND NOT UNROOFING THE PUSTULES. ON (B)(6) DR (B)(6) AND DR (B)(6) COMMUNICATED AND THE ERYTHEMA WAS IMPROVED BUT THE TISSUE WAS REPORTEDLY INDURATED PER DR (B)(6). DR (B)(6) RECOMMENDED HIGH POTENCY TOPICAL STEROIDS AS WELL AS VBEAM LASER. DR (B)(6) HAD STARTED THE GROWTH FACTORS THE SAME DAY ((B)(6)) SO DR (B)(6) RECOMMENDED DISCONTINUING THEM IN CASE SHE WAS HAVING A HYPERSENSITIVITY REACTION. DR (B)(6) ELECTED TO START HYDROCORTISONE OINTMENT FOR TWO DAYS. ON (B)(6) DR (B)(6) SENT A PICTURE THE PATIENT HAD TAKEN IN WHICH IT LOOKED AS IF THE SKIN WAS CONTINUING TO THICKEN. DR (B)(6) RECOMMENDED THE HIGH POTENCY STEROID OINTMENT AS WELL AS PULSED DYE LASER (VBEAM) AND POSSIBLY INTRALESIONAL STEROIDS IF THE TISSUE WAS VERY FIRM. THE PATIENT HAD BEEN SEEN BY A DERMATOLOGIST IN THE AREA WHO DID NOT THINK SHE NEEDED ANY DIFFERENT TREATMENT. ON TUESDAY, (B)(6) 2013 DR (B)(6) CALLED DR (B)(6) IN (B)(6) AND ASKED HER TO SEE THE PATIENT FOR DR (B)(6). DR (B)(6) WANTED ANOTHER DERMATOLOGIST TO SEE HER. DR (B)(6) REPORTED TO DR (B)(6) THAT ON TUESDAY SHE LOOKED BETTER BUT PLANNED TO SEND HER TO DR (B)(6) ANYWAY. DR (B)(6) LEFT A MESSAGE FOR DR (B)(6) STATING THAT THE PATIENT LOOKED GOOD AND SHE EXPECTED HER TO DO WELL. SHE DID NOT ELABORATE ON THE TREATMENT SHE ADMINISTERED IF ANY. ON (B)(6) 2013, DR (B)(6) COMMUNICATED TO DR (B)(6) TO ASK HOW THE PATIENT WAS DOING BUT DID NOT GET A RESPONSE. ON (B)(6) 2013, A CALL WAS PLACED TO DR (B)(6) AND HE STATED THAT THE PATIENT WAS DOING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645388 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention EPINEPHRINE| RADIESSE SYRINGE MIXED WITH LIDOCAINE AND