BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SRI-SURGICAL STERILE PACK ANGIO CATH LAB

    MDR report key: 5540353 · Received March 31, 2016

    Report

    Report Number
    5540353
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 17, 2008
    Report Date
    March 2, 2016
    Manufacturer
    UNKNOWN
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 035 WIRES STOCKED IN KIT ARE TO HAVE A "J" CURVE ON WHEN USE IN BODY, AFTER USE IN BODY "J" CURVE IS LOST AND REVERTS TO STRAIGHT CURVE WHICH COULD POTENTIALLY CAUSE PERFORATION, PLAQUE RUPTURE, NEED FOR SURGERY, OR POSSIBLY DEATH. NOTIFIED COMPANY TO WITHDRAW WIRES FROM PACK. NO ONE PARTICULAR PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195964 SRI-SURGICAL STERILE PACK ANGIO CATH LAB CUSTOM SURGICAL KIT KDD UNKNOWN CL0962L 56760

    Patients

    Seq Age Sex Outcome Treatment
    1