BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCOL

    MDR report key: 565967 · Received January 3, 2005

    Report

    Report Number
    MW1034295
    Event Type
    Injury
    Date Received
    January 3, 2005
    Date of Event
    December 29, 2004
    Report Date
    January 3, 2005
    Manufacturer
    HANCOCK JAFFE LABORATORIES
    Product Code
    FIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INITIALLY, PROBLEM IDENTIFIED AS A POSSIBLE PRODUCT PROBLEM. PT STATUS POST DIALYSIS GRAFT PLACEMENT 2 WEEKS. PRESENTED TO EMERGENCY ROOM IN FULL ARREST, BLEEDING FROM RIGHT UPPER ARM. PT SUCCESSFULLY RESUSCITATED. SURGEON NOTIFIED AND OPENED RIGHT UPPER ARM. GRAFT HAD HOLE IN IT-NOT NEAR GRAFT ANASTOMOSIS SITE. SURGEON LIGATED GRAFT. PT TO DIALYSIS AND THEN TO THE ACUTE OBSERVATION UNIT. DURING CONVERSATION WITH NEPHROLOGIST DIR OF NURSING AND THE COUSIN OF PT, COUSIN STATED THAT THE PT PHONED THEM AND TOLD THEM THEY HAD FALLEN AND WERE BLEEDING LIKE A "HOG." RPTR WAS UNAWARE OF FALL UNITL THIS TIME. BLOOD ALCOHOL LEVEL 20 - DRAWN SEVERAL HOURS AFTER ARRIVAL TO EMERGENCY ROOM. DEVICE AVAILABLE NOW. INTENT TO RETURN TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCOL VASCULAR BIOPROSTHESIS FIQ HANCOCK JAFFE LABORATORIES * SB011040

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening