BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELEVESS

    MDR report key: 1161803 · Received September 12, 2008

    Report

    Report Number
    1223628-2008-00011
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A PATIENT-REPORTED EVENT. THE PATIENT'S CONDITION HAS BEEN RESOLVED WITH THE USE OF PREDNISONE. THE BATCH RECORD, INCLUDING STERILITY TESTING RECORDS, WAS REVIEWED AND DID NOT REVEAL ANY ISSUES WITH THE ALLEGED PRODUCT LOT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED SWELLING AND REDNESS ON THE ENTIRE FACE AFTER RECEIVING AN INJECTION IN BOTH NASOLABIAL AREAS. NO OTHER SYMPTOMS WERE REPORTED. PATIENT WAS PRESCRIBED MEDROL DOSE PACK, ALEVOX AND AN ANTIHISTAMINE. A STATUS REPORT THAT WAS RECEIVED BY MANUFACTURER ONE WEEK AFTER THE INITIAL REPORTING INDICATED THAT THE SWELLING WAS RESOLVED. THE PATIENT WAS CONTINUING TO TAKE THE PREDNISONE AND ANTIBIOTIC. HOWEVER, A WEEK AFTER THAT, THE PATIENT CONDITION (SWELLING IN NASOLABIAL AREAS) RETURNED. THE PATIENT HAS BEEN PRESCRIBED STEROIDS FOR 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVESS IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANIKA THERAPEUTICS, INC. V080010AC

    Patients

    Seq Age Sex Outcome Treatment
    1 NK Required Intervention