BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EX. DRAINAGE VENTRICULAR CATH. SET

    MDR report key: 640579 · Received October 13, 2005

    Report

    Report Number
    1226348-2005-00247
    Event Type
    Injury
    Date Received
    October 13, 2005
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A
    Product Code
    JXG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFFILIATE PROVIDED ADDITIONAL INFORMATION THAT INDICATED THAT THE PRODUCT CODE WAS ACTUALLY 82-1705 AND NOT THAT OF 82-1735 AS PREVIOUSLY REPORTED. THE PRODUCT HAS NOT BEEN SENT IN FOR EVALUATION. IF AT SOME POINT THE DEVICE AND OR LOT INFORMATION DOES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE FILED. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTS THAT DURING VENTRICULAR CATHETER POSITIONING, THE TIP WAS TOO SOFT AND THE CATHETER SIZE WAS TOO LARGE RESULTING IN NOT BEIN ABLE TO PASS THE CATHETER INTO THE VENTRICULAR EPENDYMA. THE SURGEON HAD TO EVACUATE THE HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN EX. DRAINAGE VENTRICULAR CATH. SET SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC./MEDOS S.A NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention