BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOVER PREMIUM TEFLON COATED LATEX FOLEY CATH.

    MDR report key: 57133 · Received December 20, 1996

    Report

    Report Number
    9610849-1996-00011
    Event Type
    Injury
    Date Received
    December 20, 1996
    Date of Event
    November 18, 1996
    Report Date
    November 21, 1996
    Manufacturer
    SHERWOOD DAVID AND GECK
    Product Code
    FCN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO UNITS WERE RETURNED AND EVALUATED. PHYSICAL AND FUNCTIONAL TESTING, INCLUDING INFLATION, BALLOON SYMMETRY AND BURST RESISTANCE, AND BALLOON DEFLATION WERE ACCEPTABLE. LOT HISTORY WAS UNREMARKABLE WITH REGARD TO THE REPORTED PROBLEM. WITHOUT THE ACTUAL CATHETER WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    FOLEY INSERTED IN HOME CARE PT BY HOME HEALTH NURSE ON 10/21/96. DURING ATTEMPTED REMOVAL ON 11/18/96 IT WOULD NOT DEFLATE. CUT OFF VALVE AND STILL WOULD NOT DEFLATE. PT WENT TO ER ON 11/19/96. A NEEDLE WAS INSERTED THROUGH THE PERINEAL AREA THROUGH THE BLADDER TO DEFLATE THE BALLOON. PT WAS PLACED ON ANTIBIOTIC THERAPY. THE PT TOLERATED THE PROCEDURE WELL AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOVER PREMIUM TEFLON COATED LATEX FOLEY CATH. CATHETER, FOLEY FCN SHERWOOD DAVID AND GECK NA 898060

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization