BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDRELLE

    MDR report key: 1709334 · Received June 2, 2010

    Report

    Report Number
    1223628-2010-00089
    Event Type
    Other
    Date Received
    June 2, 2010
    Date of Event
    April 30, 2010
    Report Date
    May 3, 2010
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    050033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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). THE DEVICE WAS NOT AVAILABLE TO BE RETURNED. THE BATCH RECORD, INCLUDING STERILITY TESTING RECORDS, WAS REVIEWED AND MET SPECIFICATIONS, AND DID NOT REVEAL ANY ISSUES WITH THE ALLEGED PRODUCT LOT.

    Description of Event or Problem · 1

    PT WAS INJECTED WITH 1CC INTO NLF AND ORAL COMMISSURES. SHE HAD NO KNOWN ALLERGIES. TWO WEEKS LATER, SHE HAD REDNESS, SWELLING AND IT WAS TENDER AND FIRM LATERAL TO THE NLFS. HER DOCTOR INJECTED VITRASE MEDIAL TO THE AREA OF INJECTION. SHE WAS PRESCRIBED A MEDROL DOSE PACK FOR 5 DAYS AND BENADRYL. SHE HAS HAD MULTIPLE STERILE ABSCESSES LATERAL TO NLF AND IN NLF WHICH HAVE BEEN TREATED WITH KENALOG INJECTIONS, ORAL PREDNISONE AND DOXYCYCLINE. SHE HAS SINUS PRESSURE AND EYE SOCKET PAIN. ALL CULTURES FOR GRAM STAIN, AFB AND ANAEROBIC STUDIES COME BACK WITHOUT ANY BACTERIA OR WHILE CELLS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRELLE IMPLANT, DERMAL FOR AESTHETIC USE LMH ANIKA THERAPEUTICS, INC. 685-015 V080099BR

    Patients

    Seq Age Sex Outcome Treatment
    1 NK Required Intervention