BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDRELLE

    MDR report key: 1943864 · Received December 23, 2010

    Report

    Report Number
    1223628-2010-00133
    Event Type
    Other
    Date Received
    December 23, 2010
    Date of Event
    October 8, 2010
    Report Date
    December 23, 2010
    Manufacturer
    ANIKA THERAPEUTICS, INC
    Product Code
    LMH
    PMA / PMN Number
    050033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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

    AFTER THE HYDRELLE INJECTION THE PT FELT WARM PAIN, SWELLING AND REDNESS, ASPIRATION PERFORMED FOR ABSCESS AND CYST. HOSPITALIZED FOR TWO DAYS FOR DRAINING OF MULTIPLE ABSCESSES.

    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 48 YR Required Intervention