BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAMEY SUPRAPUBIC KIT

    MDR report key: 2892862 · Received December 26, 2012

    Report

    Report Number
    MW5028395
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    December 20, 2012
    Report Date
    December 26, 2012
    Manufacturer
    COOK MEDICAL
    Product Code
    KOB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING UROGYNECOLOGY PROCEDURE, TWO ATTEMPTS WERE MADE TO PLACE A SUPRAPUBIC CATHETER. THE FIRST CATHETER BROKE AT THE JOINT BETWEEN THE CATHETER AND THE BIB, THE SECOND WOULD NOT PENETRATE THE FASCIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAMEY SUPRAPUBIC KIT SUPRAPUBIC CATHETER KOB COOK MEDICAL G16922/G14099

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other