BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDRELLE

    MDR report key: 1912922 · Received November 11, 2010

    Report

    Report Number
    1223628-2010-00128
    Event Type
    Other
    Date Received
    November 11, 2010
    Report Date
    November 11, 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

    PT DID NOT CORRESPOND, 3 ATTEMPTS WERE MADE. THE DEVICE WAS NOT AVAILABLE TO BE RETURNED. PER PRODUCT LABELING, THIS 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 BROTHER STATED HIS SISTER HAD RECEIVED AN INJECTION OF HYDRELLE AND HAD A REACTION AND ENDED UP IN THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention