BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACTISEAL CL EVD 1.9MM CTH SET

    MDR report key: 3123896 · Received May 22, 2013

    Report

    Report Number
    1226348-2013-17418
    Event Type
    Injury
    Date Received
    May 22, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK021653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THERE WAS A PATIENT WHO EXHIBITED SIGNS OF AN ALLERGIC REACTION TO THE BACTISEAL EVD CATHETER. THE DOCTOR SUSPECTS THAT THE REACTION IS TO THE DRUG IN THE CATHETER. IT WAS NOTED THAT THE CATHETER WAS REPLACED ON 3-4 OCCASIONS BECAUSE IT BECAME CLOGGED QUICKLY. A PRESENCE OF EOSINOPHILIC CELLS WERE NOTED WHICH IS INDICATIVE OF A LIKELY ALLERGIC RESPONSE. NO INFORMATION WAS REPORTED ON THE OTHER DEVICES THAT WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226206 BACTISEAL CL EVD 1.9MM CTH SET SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention