BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMAGARD KNITTED VASCULAR GRAFT

    MDR report key: 2904624 · Received January 3, 2013

    Report

    Report Number
    1640201-2013-00001
    Event Type
    Other
    Date Received
    January 3, 2013
    Report Date
    December 5, 2012
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ALL INFORMATION CONTAINED IN THIS REPORT IS PROVIDED BY THE MANUFACTURER. METHOD: NO DEVICE EVALUATION WAS PERFORMED SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND THE PRODUCT IDENTIFIER WAS NOT PROVIDED. RESULTS: NO REVIEW OF THE DEVICE HISTORY RECORD WAS DONE SINCE THE PRODUCT IDENTIFIER WAS NOT PROVIDED. CONCLUSIONS: PLEASE NOT THAT THE DEVICE WAS NOT USED IN AN APPROVED INDICATION. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE GRAFT WAS USED FOR CANNULATION. IT WAS REPORTED THAT WHEN THE SURGEON STRETCHED THE GRAFT WALL. NO INJURY WAS REPORTED. IN SPITE OF REPEATED EFFORTS, NO INFORMATION ON THE PRODUCT SERIAL NUMBER COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3482 HEMAGARD KNITTED VASCULAR GRAFT DSY INTERVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other