BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 159310 · Received March 23, 1998

    Report

    Report Number
    159310
    Event Type
    Malfunction
    Date Received
    March 23, 1998
    Date of Event
    March 10, 1998
    Report Date
    March 18, 1998
    Manufacturer
    DOW CORNING CORP/ MEDICAL PRODUCTS
    Product Code
    FEW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 3/10/1998, MD ATTEMPTED TO REMOVE SUPRAPUBLIC MALECOT CATHETER. THIS WAS PLACED IN O.R. ON 2/14/1998. THE TIP OF CATHETER BROKE OFF INTERNALLY. RETAINED SECTION WAS SURGICALLY REMOVED DURING EXPLORATION ON 3/10/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant SILICONE MALECOT SUPRAPUBIC CATHETER FEW DOW CORNING CORP/ MEDICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other