BEUDAMED
    FDA Adverse Event Summary report: N

    U.S. SURGICAL

    MDR report key: 453232 · Received April 10, 2003

    Report

    Report Number
    453232
    Date Received
    April 10, 2003
    Date of Event
    March 19, 2003
    Report Date
    March 25, 2003
    Manufacturer
    U.S. SURGICAL
    Product Code
    GAO
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    2-0 SURGIPRO ON V-26 NEEDLE USED DURING AORTIC PROCEDURE. TIP OF NEEDLE BROKE TRYING TO GO THROUGH THE AORTA. X-RAY REQUESTED-NEEDLE WAS NOT VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U.S. SURGICAL NEEDLE AND SUTURE GAO U.S. SURGICAL 2-0 SURGIPRO ON V-26 NEEDLE *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR