BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELEVESS

    MDR report key: 1161804 · Received September 12, 2008

    Report

    Report Number
    1223628-2008-00010
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 8, 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 IS CURRENTLY RESOLVED. PER PRODUCT LABELING, THE PRODUCT IS INDICATED FOR USE IN MID TO DEEP DERMIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS). THE USE OF THE DEVICE OUTSIDE OF LABELING INDICATIONS IS CONSIDERED AS UNAPPROVED USE. 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 IN BOTH THE UPPER AND LOWER LIP AFTER INJECTION IN BOTH AREAS. NO OTHER SYMPTOMS WERE REPORTED. PATIENT WAS PRESCRIBED ORAL PREDNISONE AND AN ANTIHISTAMINE. AFTER TWO DOSES, THE PATIENT CEASED USAGE SINCE THE SWELLING WAS RESOLVED.

    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