BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAWRENCE SUPRAFOLEY - SUPRAPUBIC CATH

    MDR report key: 2163581 · Received July 12, 2011

    Report

    Report Number
    MW5021323
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    TELEFLEX - RUSCH
    Product Code
    KOB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON PLACED LAWRENCE SUPRAPUBIC CATHETER INTRODUCER, BUT WAS UNABLE TO THREAD A CATHETER. A PIECE BROKE OF THE OUTER SHEATH OF THE INTRODUCER CAUSING THE OUTER SHEATH TO BE "SUCKED" INTO THE ABDOMEN. THE INCISION WAS EXTENDED TO REMOVE THE SHEATH. SURGEON QUESTIONS DEVICE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAWRENCE SUPRAFOLEY - SUPRAPUBIC CATH SUPRAPUBIC CATH INTRODUCER KOB TELEFLEX - RUSCH AC851 IRU-516-856 24369

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention