BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3912347 · Received June 27, 2014

    Report

    Report Number
    2135225-2014-00044
    Event Type
    Other
    Date Received
    June 27, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE SAME DAY, (B)(6) 2014, AS A FOLLOW-UP TO DR. (B)(6)'S STATEMENT, DR. (B)(6) WAS CONTACTED AND SHE STATED THE PATIENT WAS DIAGNOSED WITH CELLULITIS DUE TO A BLOW INTO HER FACE. WHILE IN THE HOSPITAL, THE PATIENT WAS ON IV ANTIBIOTICS. THE CELLULITIS RESOLVED AND THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2014. SHE ALSO STATED THE EVENTS ARE NOT RELATED TO RADIESSE AND WERE ATTRIBUTED TO A PATIENT BEING HIT IN A FACE. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOTS WERE REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECIFICATIONS FOR THESE LOT WERE MET PRIOR TO RELEASE.

    Description of Event or Problem · 1

    DR. (B)(6) STATED A FEMALE PATIENT WAS INJECTED ON (B)(6) 2014 WITH 0.8 CC RADIESSE DIVIDED EQUALLY INTO HER CHEEKS; 0.2 CC LIDOCAINE WAS MIXED WITH RADIESSE PRIOR TO INJECTIONS. ON FRIDAY OR SATURDAY (DR. WAS NOT SURE) THE PATIENT WAS ACCIDENTLY HIT INTO HER CHEEK'S INJECTED AREA. SHE HAS REDNESS AND SWELLING IN THE AREA. THE PATIENT NOTIFIED DR. ON (B)(6) 2014, THAT SHE IS HAVING REDNESS, SWELLING AND DIFFICULTY BREATHING. THE PATIENT WAS OUT OF TOWN. DR. (B)(6) PRESCRIBED KEFLEX, 250MG PO BID AS A PROPHYLACTIC. ON (B)(6) 2014, THE PATIENT WAS SEEN BY DR. (B)(6) AND WAS TOLD TO GO TO THE EMERGENCY ROOM (ER). THE NURSE PRACTITIONER (NP) AT THE ER EXAMINED THE PATIENT AND DIAGNOSED HER WITH REDNESS AND EDEMA; NO ISSUES WITH RESPIRATIONS. THE NP CONSULTED WITH DR. (B)(6) AND WAS TOLD THE PATIENT HAS BEEN INJECTED WITH RADIESSE THE PREVIOUS WEEK. THE NP ORDERED A CAT SCAN; RESULT WAS "DEBRIS, RADIO OPAQUE SUBSTANCE." THE PATIENT WAS HOSPITALIZED AND PLACED ON PROPHYLACTIC IV ANTIBIOTIC, NO DETAILS KNOWN, FOR A POSSIBLE CELLULITIS. (B)(4), DR. (B)(6) WAS ASKED FOR CONSULTATION REGARDING THIS PATIENT. DURING A CALL TO DR. (B)(6)'S OFFICE, HE WAS TOLD THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376352 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC. 100062718

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R 0.2 CC LIDOCAINE MIXED WITH RADIESSE SYRINGE