BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEPARIN-COATED PENTALUMEN TD CATHETER

    MDR report key: 55861 · Received September 27, 1996

    Report

    Report Number
    1713468-1996-00003
    Event Type
    Other
    Date Received
    September 27, 1996
    Date of Event
    April 28, 1996
    Report Date
    September 24, 1996
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DYG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED VIA MAIL FROM RISK MGR THAT READS: "PT SUSTAINED A LACERATION OF THE PULMONARY ARTERY A FEW MINUTES AFTER A WEDGE PROCEDURE WAS DONE BY THE PHYSICIAN." OTHER THAN PRODUCT IDENTIFICATION, THERE WAS NO FURTHER INFO IN THE REPORT. MULTIPLE MESSAGES HAVE BEEN LEFT AT THE HOSP RISK MGR'S NUMBER IN ATTEMPTS TO OBTAIN MORE INFO, NO CALL BACK HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN-COATED PENTALUMEN TD CATHETER THERMODILUTION CATHETER DYG ABBOTT LABORATORIES NA 00-000-SN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other