BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEALPTFE VASCULAR GRAFT

    MDR report key: 1832193 · Received September 3, 2010

    Report

    Report Number
    MW5017342
    Event Type
    Injury
    Date Received
    September 3, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    VASCUTEK
    Product Code
    DSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS END STAGE RENAL DISEASE AND UNDERSENT IMPLANTATION OF GELATIN SEALED PTFE DIALYSIS GRAFT (B)(6)2010. POSTOP SHE HAD MORE SWELLING THAN EXPECTED AND FLUID AROUND THE GRAFT. SHE WAS READMITTED WITH INFECTED PTFE GRAFT WHICH WAS EXPLANTED (B)(6)2010. DATES OF USE: (B)(6)2010 -- (B)(6)2010. DIAGNOSIS OR REASON FOR USE: DIALYSIS ACCESS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALPTFE VASCULAR GRAFT GELATIN SEALED VASCULAR GRAFT DSY VASCUTEK #P1931-1A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L