BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-STAT DRY HEMOSTATIC BANDAGE

    MDR report key: 2489955 · Received April 14, 2011

    Report

    Report Number
    2489955
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 12, 2011
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH PREVIOUS PACEMAKER UNDERWENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR / PACEMAKER UPGRADE. DURING PROCEDURE, D-STAT DRY HEMOSTATIC BANDAGE WAS PLACED INTO PACEMAKER POCKET TO AID BLEEDING CONTROL. POCKET WAS CLOSED AND PROCEDURE ENDED. A FEW HOURS LATER STAFF DETERMINED D-STAT WAS NOT IMPLANTABLE. PT WAS INFORMED AND RETURNED TO CATHLAB FOR POCKET REMOVAL OF D-STAT BANDAGE. FURTHER COMPLAINTS OR ISSUES MODIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-STAT DRY HEMOSTATIC BANDAGE HEMOSTATIC BANDAGE-TOPICAL FRO VASCULAR SOLUTIONS, INC. 3000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention