BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE 1 - MILTEX

    MDR report key: 232865 · Received July 29, 1999

    Report

    Report Number
    232865
    Event Type
    Injury
    Date Received
    July 29, 1999
    Date of Event
    July 14, 1999
    Report Date
    July 21, 1999
    Manufacturer
    MILTEX INSTRUMENT CO. INC.
    Product Code
    HDQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CERVICAL DILATATION AND HYSTEROSCOPY, UTERINE PERFORATION SUSPECTED. PROCEDURE ABORTED AFTER SERIAL CERVICAL DILATION TO APPROX 7MM AND PLACEMENT OF HYSTEROSCOPE. INTRA-OPERATIVE CONSULT TO ASSIST WITH DIAGNOSTIC LAPAROSCOPY DETECTED A SMALL PERFORATION APPROXIMATELY 1 CM IN DIAMETER ALONG THE POSTERIOR CERVIX NEAR THE LOWER UTERINE SEGMENT. NO BLEEDING NOTED; SMALL AMOUNT OF BLOOD ASPIRATED WITH COPIOUS IRRIGATION. PROCEDURE ABORTED AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE 1 - MILTEX CERVICAL HEGAR DILATORS HDQ MILTEX INSTRUMENT CO. INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention HYSTEROSCOPE.