BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 4054670 · Received August 26, 2014

    Report

    Report Number
    2135225-2014-00054
    Event Type
    Other
    Date Received
    August 26, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MERZ N.A. 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

    DR (B)(4) CONTACTED DR (B)(6) AND REPORTED THE PHOTO RECEIVED DEMONSTRATES A VASCULAR OCCLUSION OF THE FACIAL AND LATERAL NASAL ARTERY WITH SPREAD INTO THE ANASTOMOSED DORSAL NASAL ARTERY. DR (B)(4) ADVISED SUPPORTIVE CARE; HYPERBARIC OXYGEN, ASPIRIN, ANTIBIOTICS, ANTIVIRALS, MAINTAIN MOISTURE WITH AQUAPHOR AND DO NOT DEBRIDE UNTIL TISSUE HAS CLEARLY DEMARCATED. ALSO ADVISED WAS CLOSE FOLLOW-UP AND A REFERRAL TO A PLASTIC SURGEON. ON (B)(6) 2014 DR (B)(6) CONTACTED DR (B)(4) STATING HE TRIED TO CONTACT THE PATIENT HOWEVER SHE IS NO LONGER RETURNING HIS CALLS. DR (B)(6) LEFT HER A SECOND MESSAGE ADVISING HER OF DR (B)(4) RECOMMENDATIONS AND THAT HE HAD SET UP AN APPOINTMENT WITH A PLASTIC SURGEON FOR HER PLUS HYPERBARIC OXYGEN TREATMENTS. A SHORT WHILE LATER THE PATIENT'S HUSBAND CALLED DR (B)(6) TO REPORT THE PATIENT IS NOW SEEING A DERMATOLOGIST WHO TREATED HER WITH NITRO PASTE. THE PATIENT WILL FOLLOW-UP WITH THE DERMATOLOGIST AND HAS NO INTEREST IN SEEING THE PLASTIC SURGEON. ON (B)(6) 2014 THE PATIENT'S HUSBAND CONTACTED MERZ REQUESTING A MEDICAL CONSULT FOR THE DERMATOLOGIST. MERZ CONTACTED THE DERMATOLOGIST'S OFFICE AND WAS INFORMED A MEDICAL CONSULT WAS NOT NECESSARY. THE DEVICE HISTORY RECORD FOR RADIESSE LOT #100066131 WAS REVIEWED. ALL REQUIRED 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 A (B)(6) FEMALE PATIENT WAS INJECTED WITH 1.5CC OF RADIESSE IN THE NASOLABIAL FOLDS BY DR (B)(6). THE PATIENT DEVELOPED INCREASING SWELLING AND REPORTED GOING TO URGENT CARE ON (B)(6) 2014 WHERE SHE RECEIVED IV AND ORAL ANTIBIOTICS AND A TOPICAL STEROID CREAM. THE PATIENT WAS LAST SEEN IN DR (B)(6) OFFICE ON (B)(6) 2014 WITH BRUISING, REDNESS AND SWELLING BUT NO BLISTERING. DR (B)(6) TREATED HER WITH 4 MG DECADRON, IM. ON (B)(6) 2014 DR (B)(6) OFFICE MANAGER CONTACTED MERZ PRODUCT SAFETY REPORTING THE PATIENT'S SWELLING IS INCREASING AND HER HUSBAND HAD JUST CALLED REPORTING THE AREA IS WORSENING; IT HAS BROKEN OPEN WITH PUS OOZING AND IS VERY BLACK AND BLUE. A MEDICAL CONSULT FOR DR (B)(6) WAS PROVIDED BY A MERZ FIELD CLINICAL SPECIALIST (FCS). THE FCS RECEIVED PATIENT PHOTOS AND DISCUSSED THE POSSIBILITY THAT THIS COULD BE A VASCULAR EVENT WITH DR (B)(6). THE DECISION WAS MADE TO ELEVATE THE EVENT TO MERZ (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518101 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ N.A. INC. 100066131

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SYRINGE MIXED WITH UNKNOWN VOLUME OF LIDOCAINE