BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3370365 · Received September 13, 2013

    Report

    Report Number
    2135225-2013-00092
    Event Type
    Other
    Date Received
    September 13, 2013
    Date of Event
    August 10, 2013
    Report Date
    August 15, 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

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT WERE NOT REVIEWED AS THE LOT NUMBER WAS UNK. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013 A MERZ NORTH AMERICA, INC FIELD CLINICAL SPECIALIST (FCS) NOTIFIED (B)(6) THAT DR (B)(6) HAD CALLED HER REGARDING A PT WHO HAD POSSIBLE NECROSIS OR AN OCCLUSION TO THE ANGULAR ARTERY POST RADIESSE INJECTION INTO THE NLFS. ON (B)(6) 2013, (B)(6) SPOKE TO DR (B)(6). THE PT WAS INJECTED ON (B)(6) 2013 USING TWO 1.5CC RDF SYRINGES (DR STOLL STATES THAT HE DID NOT USE A FULL SECOND SYRINGE). HE REPORTS THAT DURING INJECTION HE DID NOT SEE ANY BLANCHING OF THE SKIN. THE PT DID NOT REPORT ANY PAIN, SWELLING, ERYTHEMA, OR WARMTH TO THE AREA IMMEDIATE FOLLOWING INJECTION OR IN THE FIRST 24 HRS AFTER INJECTION. ON SATURDAY, THE PT BEGAN TO DEVELOP PUSTULAR LESIONS IN THE LEFT NLF EXTENDING TO THE PIRIFORM APERTURE AND LEFT NASAL ALAR. UPON QUESTIONING DR (B)(6) DOES NOT REPORT ANY DUSKY NOR MOTTLED APPEARANCE OF THE SKIN. DURING THE PHONE CONVERSATION, DR (B)(6) EMAILED ME A PHOTO OF THE PT. AS WE REVIEWED THE PHOTO TOGETHER, WE DISCUSSED THAT THE PT DID NOT DEMONSTRATE ANY CLASSIC SIGNS OF AN ANGULAR ARTERY OCCLUSION; THIS IS MOST LIKELY A HERPETIC OUTBREAK. DR (B)(6) STATED THAT HE HAS THE PT ON ANTIBIOTICS AND HE PLANS TO TREAT AGGRESSIVELY FOR A HERPETIC OUTBREAK. ON (B)(6) 2013, A F/U CALL WAS PLACED TO DR (B)(6). HE WAS ASKED IF THERE WAS ANY NECROSIS. HE STATED, NO. HE WAS ASKED IF THIS WAS A HERPETIC OUTBREAK. HE ANSWERED, POSSIBLY. HE WAS ASKED IF THE ANTIBIOTIC WAS PRESCRIBED PROPHYLACTICALLY OR BECAUSE IT WAS THOUGHT THAT THERE WAS AN INFECTION. HE STATED THAT HE DID NOT PRESCRIBE THE ANTIBIOTIC. THE PT (SHE) WENT TO EITHER HER REGULAR DOCTOR OR AN ER OR AN URGENT CARE FACILITY AND THEY ARE THE ONES THAT PRESCRIBED THE ANTIBIOTIC. HE BELIEVES THAT THE ANTIBIOTIC WAS GIVEN TO TREAT AN INFECTION. HE HAS TREATED THE PT BY PRESCRIBING VALTREX 2G TWO TIMES A DAY FOR 1 DAY. HE WAS ASKED IF THE PT HAS COME IN FOR A F/U VISIT. HE STATED YES AND THAT THE PT STILL HAS PUSTULES. ON (B)(6) 2013 DR (B)(6) CALLED. HE STATED THAT HE JUST SAW THE PT 20 MINUTES AGO. THE PUSINESS HAS GONE AWAY. THERE ARE FIRM NODULES WHERE THE HERPETIC OUT BREAK WAS. THERE MAY BE RESIDUAL SCARRING. THIS IS ON THE NOSE. THERE IS HYPERTROPHIC TISSUE (OVER GROWN BUMPS) ON THE NOSE. IT MAY TAKE A LASER TREATMENT OR TWO TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461993 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ NORTH AMERICA INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention