BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTS INLIN VLV W/UNIT BAC CAT

    MDR report key: 3040355 · Received April 8, 2013

    Report

    Report Number
    1226348-2013-14957
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Product Problem
    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 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.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER INITIALLY REPORTED WAS NOT VALID FOR THE PRODUCT REPORTED. 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.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PATIENT DEVELOPED SUBCUTANEOUS SWELLING. IT WAS ALSO REPORTED THAT THE DEVICE MAY HAVE ONLY BEEN FIXED WITH ONE SUTURE. THE PRESSURE OF THE DEVICE WAS CHANGED AND AT THE PRESENT TIME NO ADDITIONAL MEDICAL INTERVENTION IS REQUIRED. THE SWELLING IS DECREASING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143268 CERTS INLIN VLV W/UNIT BAC CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CNKBDY

    Patients

    Seq Age Sex Outcome Treatment
    1