BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMAGARD KNITTED GRAFT

    MDR report key: 3925396 · Received June 16, 2014

    Report

    Report Number
    1640201-2014-00016
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 20, 2014
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ALL INFO CONTAINED IN THIS REPORT IS PROVIDED BY THE MFR. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING COLLAGEN COATING RECORDS, INDICATED THAT THE PRODUCT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO ANOMALY WAS FOUND. SPECIFICALLY, THE REVIEW OF THE WATER PERMEABILITY TESTING OF PRODUCTS COATED ON THE SAME DAY AND UNDER THE SAME CONDITIONS AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. NO CONCLUSION CAN BE DRAWN. HOWEVER, ALL AVAILABLE INFO WOULD TEND TO INDICATE THAT THE DEVICE WAS NOT DEFECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VASCULAR SURGERY PERFORMED ON (B)(6) 2014, BLEEDING OCCURRED FROM THE GRAFT, WHICH NECESSITATED BLOOD TRANSFUSION. THE GRAFT REMAINED IMPLANTED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351936 HEMAGARD KNITTED GRAFT VASCULAR GRAFT PROSTHESIS DSY INTERVASCULAR HGK0008-40 13G18

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention