BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATION TUBING

    MDR report key: 4428604 · Received January 16, 2015

    Report

    Report Number
    1226348-2015-10043
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    December 17, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    GEI
    PMA / PMN Number
    PK890648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT IS BEING FILED AS IT WAS COMMUNICATED THAT THE MEDWATCH REPORT SUBMITTED UNDER MEDWATCH # MW-180401 WAS ALREADY SUBMITTED IN A SEPARATE COMPLAINT THAT WAS OPENED TO ADDRESS THIS ISSUE UNDER (B)(4). AS A RESULT THIS COMPLAINT IS BEING CLOSED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION FOR COMPLAINT (B)(4). (B)(4).

    Description of Event or Problem · 1

    A KINK WAS FOUND WITH 40 PRODUCTS DURING SETUP. THE DEVICES WERE USED WITH (B)(4). USER TRAINING IS SCHEDULED TO BE DONE. THERE WERE NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. (B)(6) 2014, COMPLAINT WAS RE-OPENED AS ADDITIONAL INFORMATION WAS RECEIVED. COMPLAINT IS NOW REPORTABLE. REGARDING (B)(4), IN ADDITION TO KINK, FOREIGN MATTER (HAIR) WAS FOUND IN ONE OF THE PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39634 IRRIGATION TUBING IRRIGATION TUBING SET, GENERAL PURPOSE GEI CODMAN & SHURTLEFF, INC 558796

    Patients

    Seq Age Sex Outcome Treatment
    1