BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDRELLE

    MDR report key: 2474694 · Received February 11, 2011

    Report

    Report Number
    1223628-2011-00004
    Event Type
    Other
    Date Received
    February 11, 2011
    Date of Event
    February 26, 2011
    Report Date
    January 26, 2011
    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 IN THE NLF'S ON (B)(6) 2010, THE LEFT SIDE FORMED A BUMPED ON THE NASAL AREA. (B)(6) 2010, THE BUMP UP CONTINUED TO GROW AND ON (B)(6) 2010 AND (B)(6), 2010 THE PT WENT TO THE DERMATOLOGIST. THE DERMATOLOGIST PRESCRIBED CEPHALEXIN. ON (B)(6), 2010 A BUMP DEVELOPED ON THE RIGHT SIDE OF THE NLF, A NEEDLE EXTRACTION OF STERILE ABSCESS WAS PERFORMED ON (B)(6), 2010 AND THE PROCEDURE WAS REPEATED ON (B)(6), 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention