BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANSFIELD EP

    MDR report key: 249572 · Received November 10, 1999

    Report

    Report Number
    MW1017533
    Event Type
    Malfunction
    Date Received
    November 10, 1999
    Date of Event
    November 9, 1999
    Report Date
    November 10, 1999
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM MFR ON 12/23/99: BOSTON SCIENTIFIC CORP. IS THE DISTRIBUTOR, NOT THE MFR OF THE INTRODUCER SHEATH IN QUESTION. THOMAS MEDICAL, THE MFR, HAS FILED A MEDWATCH REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANSFIELD EP INTRODUCER SHEATH DYB BOSTON SCIENTIFIC CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR