BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDRELLE

    MDR report key: 1749884 · Received July 7, 2010

    Report

    Report Number
    1223628-2010-00109
    Event Type
    Other
    Date Received
    July 7, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 6, 2010
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    050033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    PATIENT HAD NORMAL SWELLING AFTER INJECTION THAT WENT DOWN. THREE WEEKS LATER, SHE HAD SWELLING THROUGHOUT HER FACE, HER EYES, NOSE, NLF, ETC., AND SHE FELT HARD MATERIAL IN THE NLF. SHE WAS PUT ON OTC BENADRYL. HER DOCTOR ALSO LATER PRESCRIBED A MEDROL DOSE PACK.

    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 NK Required Intervention