BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE

    MDR report key: 4017923 · Received August 18, 2014

    Report

    Report Number
    1226348-2014-11905
    Event Type
    Injury
    Date Received
    August 18, 2014
    Date of Event
    August 6, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK122118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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 NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT: "CAM FELL OFF. VALVE WAS REPLACED WITH ANOTHER CODMAN VALVE ON (B)(6) 2014. SALES REP. DOES NOT KNOW IF THE CUSTOMER KEPT THE EXPLANTED VALVE". ON (B)(6) 2014, THE SALES REP. PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: "THE VALVE WAS REPLACED WITH THE SAME TYPE OF VALVE (P/N 82-3851), AND THE PATIENT'S CONDITION WAS GOOD AFTER THE REVISION SURGERY. THE PATIENT HAD NO TRAUMA AND NO EXCESSIVE MRI. THE HOSPITAL DID NOT SAVE THE VALVE FOR EVALUATION. PLEASE SEND A WARRANTY REPLACEMENT TO THE SALES REP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496121 VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention