BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MALECOT CATHETER

    MDR report key: 176245 · Received July 7, 1998

    Report

    Report Number
    1816403-1998-00308
    Event Type
    Injury
    Date Received
    July 7, 1998
    Date of Event
    March 10, 1998
    Report Date
    March 18, 1998
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FEW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 3/10/98, MD ATTEMPTED TO REMOVE SUPRAPUBIC MALECOT CATHETER. THIS WAS PLACED IN O.R. ON 2/14/98. TIP OF CATHETER BROKE OFF INTERNALLY. RETAINED SECTION WAS SURGICALLY REMOVED DURING EXPLORATION ON 3/10/98. THE PT APPEARS TO HAVE HAD A WOUND INFECTION POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MALECOT CATHETER Implant MALECOT CATHETER FEW DOW CORNING CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention