BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDRELLE

    MDR report key: 1943540 · Received December 3, 2010

    Report

    Report Number
    1223628-2010-00129
    Event Type
    Other
    Date Received
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    050033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER PRODUCT LABELING, THE PRODUCT IS INDICATED FOR USE IN THE MID TO DEEP DERMIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS SUCH AS NASOLABIAL FOLDS.

    Description of Event or Problem · 1

    PT WAS INJECTED UNDER THE EYES AND FROWN LINES. THREE - FOUR WEEKS AFTER THE INJECTIONS THE PT HAD FACIAL SWELLING AND MULTIPLE ABSCESSES. APPROX 6 WEEKS AFTER THE INJECTIONS THE PT WAS HOSPITALIZED DUE TO FACIAL SWELLING AND MULTIPLE ABSCESSES. PT HAD STEROID INJECTIONS AND SEVERAL ROUNDS OF ANTIBIOTICS. CAT SCAN INDICATED NO INFECTION AND HYALURONIDASE WAS ALSO GIVEN. PT UPDATE ON (B)(6) 2010, THE PATIENT'S DERMATOLOGIST PRESCRIBED SINGULAR FOR HER FACIAL SWELLING AND THE PT SWELLING IMPROVED AND THE PT IS FULLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRELLE IMPLANT, DERMAL FOR AESTHETIC USE LMH ANIKA THERAPEUTICS, INC. 685-015 V090044BA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R