BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDRELLE

    MDR report key: 2011823 · Received February 24, 2011

    Report

    Report Number
    1223628-2011-00010
    Event Type
    Other
    Date Received
    February 24, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    050033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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 HAD AN INJECTION OF HYDRELLE AND HAD PAIN, SWELLING, REDNESS, CYST AND DRAINAGE. THE PT WAS PUT ON PREDNISONE. PT STILL HAS SWELLING AND REDNESS AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRELLE IMPLANT, DERMAL FOR AESTHETIC USE LMH ANIKA THERAPEUTICS, INC. 685-015 V090074BB

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention