BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLING-WECK

    MDR report key: 5722598 · Received September 15, 2004

    Report

    Report Number
    5722598
    Event Type
    Injury
    Date Received
    September 15, 2004
    Date of Event
    August 11, 2004
    Report Date
    August 13, 2004
    Manufacturer
    PILLING-WECK
    Product Code
    MGZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HEAD OF VALVULOTOME BROKE OFF INSIDE VESSEL DURING RIGHT INSITU BYPASS (LOWER EXTREMITY) PROCEDURE. DISTAL END OF VESSEL DAMAGED AND REMOVED. REQUIRED EXTENSION OF INCISION AND PROLONGED PROCEDURE TIME. MFR REF: 2515651-2004-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING-WECK VALVULOTOME MGZ PILLING-WECK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention