BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 189413 · Received December 23, 1996

    Report

    Report Number
    189413
    Event Type
    Injury
    Date Received
    December 23, 1996
    Date of Event
    November 5, 1996
    Report Date
    November 18, 1996
    Manufacturer
    BARD UROLOGICAL DIVISION/C.R. BARD, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED IN ACCORDANCE WITH THE SAFE MEDICAL DEVICE ACT OF 1990 AS AMENDED TO 1992 IN PUBLIC LAW 002-300 AND AS PUBLISHED IN THE FEDERAL REGISTER DECEMBER 11, 1995 AND BY SUBMISSION IS NOT TO BE INTERPRETED AS AN ADMISSION OF NEGLIGENCE OR FAULT ON THE CERVIX MIGRATED OUT A PREVIOUSLY UNK PERFORATION-NECESSITATING SURGICAL REMOVAL FROM THE ABDOMINAL CAVITY. 12/19/96 REVISED REPORT: A PERFORATION OF THE PT'S UTERUS OCCURRED DURING A COMPLICATED DILATION OF THE CERVIX. ADDITIONALLY A CATHETER WAS PLACED INTO THE UTERINE CAVITY TO ACT AS A STENT. POSTOPERATIVELY IT BECAME APPARENT THAT THE CATHETER MIGRATED THROUGH THE UNBEKNOWNEST PERFORATION REQUIRING LAPAROSCOPIC REMOVAL. MULTIPLE DILATERS RANGING FROM A LACRIMAL PROBE TO NO GREATER THAN A 13MM HAGER DILATOR WAS ATTEMPTED. SINCE IDENTIFIED POSTOPERATIVELY, DEVICE ID OR SUPPLIER IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD Implant FOLEY CATHETER KOD BARD UROLOGICAL DIVISION/C.R. BARD, INC. * 39FGN033

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R