BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLEABLE CATHETER PASSER, LONG

    MDR report key: 2901366 · Received January 8, 2013

    Report

    Report Number
    1226348-2013-10573
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 13, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    KGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE UNI-SHUNT PASSER BROKE DURING USE AND THE PIECE MAY BE LEFT IN THE BODY. IT IS NOT CLEAR IF A PIECE OF MATERIAL WAS LEFT IN THE PATIENT. MORE INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9961 MALLEABLE CATHETER PASSER, LONG ACCESSORIES, CATHETER KGZ CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention