BEUDAMED
    FDA Adverse Event Summary report: N

    24FR 30CC LATEX COUDE TIP

    MDR report key: 381435 · Received March 7, 2002

    Report

    Report Number
    9611712-2002-00001
    Date Received
    March 7, 2002
    Date of Event
    February 11, 2002
    Report Date
    March 7, 2002
    Manufacturer
    THE KENDALL COMPANY
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON ALLEGEDLY WOULD NOT DEFLATE. AFTER A TRANSURETHRAL PROSTATE RESECTION TRACTION PLACED ON FOLEY AND SECURED. BALLOON WOULD NOT DEFLATE. HAD TO REOPEN PATIENT TO CHANGE CATHETER. KENDALL INFORMED ON 03/2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 24FR 30CC LATEX COUDE TIP * KOD THE KENDALL COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other