BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPROCURE SINUS TARSI STENT

    MDR report key: 3576915 · Received January 6, 2014

    Report

    Report Number
    3004993707-2014-00001
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    May 3, 2012
    Report Date
    January 2, 2014
    Manufacturer
    GRAHAM MEDICAL TECHNOLOGIES LLC (DBA GRAMEDICA)
    Product Code
    HWC
    PMA / PMN Number
    K042030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCTOR REPORTED TO DISTRIBUTOR THAT A HYPROCURE STENT WAS PULLED OUT TWO WEEKS POST-OP BY DUE TO SWELLING AND REDNESS. A BIOPSY WAS DONE TO REPORT A PSEUDO-SEPTIC REACTION. DOCTOR WOULD LIKE TO KNOW IF THERE IS A HISTORY OF PSEUDO-SEPTIC REACTIONS. GRAMEDICA DOES NOT HAVE A HISTORY OF PSEUDO-SEPTIC REACTIONS. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION/TESTING. A REVIEW OF THE MANUFACTURING PAPERWORK (DEVICE RECORDS) OF THE SAME LOT WAS EVALUATED AND REVEALED THAT THE PROCESSES WERE MET ACCORDING TO THE DEVICE MASTER RECORD. A REVIEW OF OUR INSPECTION PAPERWORK (DEVICE RECORDS) ALSO CONFIRMED THAT THE MFG PROCESSES WERE MET ACCORDING THE DEVICE MASTER RECORD. INHERENT RISKS OF SURGICAL PROCEDURE DOCUMENTED ON THE DEVICE LABELING (PACKAGE INSERT).

    Description of Event or Problem · 1

    A HYPROCURE SIZE 6 STENT WAS REMOVED TWO WEEKS POST-OP BY A PHYSICIAN DUE TO SWELLING AND REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8349 HYPROCURE SINUS TARSI STENT SUBTALAR IMPLANT HWC GRAHAM MEDICAL TECHNOLOGIES LLC (DBA GRAMEDICA) HYP-06 060819102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention