BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDRELLE

    MDR report key: 1628703 · Received March 8, 2010

    Report

    Report Number
    1223628-2010-00031
    Event Type
    Other
    Date Received
    March 8, 2010
    Date of Event
    December 1, 2009
    Report Date
    March 8, 2010
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    050033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 ON (B)(6) 2009 IN THE NLF'S. TWO MONTHS LATER, SHE DEVELOPED SWELLING WITH PAIN ON BOTH NLF'S. SHE WAS GIVEN DOXYCYCLINE 100MG 2 PER DAY FOR ABOUT A WEEK, AS WELL AS A MEDROL DOSE PACK. NOW SHE IS TAKING Z-PAK FOR 6 DAYS. HER RIGHT NLF HAS OPENED AND DRAINED; BUT THE LEFT HAS NOT. THERE IS NOTHING TO CULTURE AS IT DRAINED SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRELLE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANIKA THERAPEUTICS, INC. 685-015 V080107BA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention