BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTX 2WY 30CC CATH

    MDR report key: 334335 · Received February 23, 2001

    Report

    Report Number
    2183558-2000-00019
    Event Type
    Injury
    Date Received
    February 23, 2001
    Date of Event
    August 31, 2000
    Report Date
    September 24, 2000
    Manufacturer
    MENTOR CORP-MINNESOTA DIVISION
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER NEEDED TO GO TO THE EMERGENCY ROOM TO HAVE FOLEY CATHETER DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7704 LTX 2WY 30CC CATH SIL COATED LATEX IND.CAT KOD MENTOR CORP-MINNESOTA DIVISION UC2318 99A03R

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R