BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN LUMBAR CATHETER KIT

    MDR report key: 4102146 · Received September 19, 2014

    Report

    Report Number
    1226348-2014-11993
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 16, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK964923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE 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 NOT RETURNED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: I WAS TOLD TODAY AT 12:00 THAT ONE SURGEON HAD A PROBLEM WITH OUR CODMAN LUMBAR DRAINAGE KIT II. I HAVE BEEN TOLD THAT SOME PIECES OF THE PRODUCT WAS LEFT INSIDE THE PATIENT. THEY FOUND OUT ABOUT THIS WHEN X-RAY WAS PERFORMED. THE HEAD OF THE PO DEPARTMENT WILL MAKE SURE THAT THE SURGEON WILL CONTACT ME FOR FURTHER INFORMATION. THIS IS ALL I KNOW RIGHT NOW. THE DEPARTMENT HAS REPORTED THIS AS A DEVIATION TO THE PURCHASE DEPARTMENT. (DURING USE ON PATIENT) SAMPLE DISCARDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584238 CODMAN LUMBAR CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. 525127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention