BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYVEK PATCH

    MDR report key: 560760 · Received December 21, 2004

    Report

    Report Number
    560760
    Event Type
    Other
    Date Received
    December 21, 2004
    Date of Event
    November 19, 2004
    Report Date
    December 16, 2004
    Manufacturer
    SYVEK
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    S/P DIAGNOSTIC CATH SYVEK WITH SHEATH REMOVED PATCH WAS USED FOR CLOSING UP. PT WAS ON BR X 2 HRS. AND AMBULATED HELD FOR ANOTHER 2 HRS. WHEN PT WAS DRESSING TO GO HOME FELT SEVERE RLQ PAIN. FIRM AREA NOTED OVER SYVEK PATCH SITE. MANUAL PRESSURE APPLIED FURTHER BR. VASCULAR SURGERY CONSULT, US SHOWED PSEUDOANEURYSM. VASCULAR SURGION INJECTED THROMBIN AT SITE AND BR X4 HR. REPEAT US SHOWED NO PSEUDO. PT D/C IN AM WITH FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYVEK PATCH VASCULAR CLOSURE DEVICE FTM SYVEK * 031203

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other