BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARDEX FOLEY CATHETER

    MDR report key: 40197 · Received September 10, 1996

    Report

    Report Number
    1018233-1996-00001_2
    Event Type
    Other
    Date Received
    September 10, 1996
    Date of Event
    August 9, 1996
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLEY-CATHETER WAS INSERTED ON 8/2/96 FOLLOWING STONE REMOVAL PROCEDURE. ON 8/7/96, CATH BALLOON WOULD NOT DEFLATE FOR CATHETER REMOVAL. DR INJECTE D MINERAL OIL INTO BALLOON & WAITED 24 HRS. DR THEN INJECTED ALCOHOL INTO BALLOON & THE BALLOON BURST. A CYSTOSCOPY WAS PERFORMED TO REMOVE BALLOON FRAGMENTS FROM THE PTS BLADDER. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX FOLEY CATHETER FOLEY CATHETER KOD C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other
    2