BEUDAMED
    FDA Adverse Event Other Summary report: N

    FALLOPOSCOPE

    MDR report key: 58695 · Received December 24, 1996

    Report

    Report Number
    2951250-1996-00003
    Event Type
    Other
    Date Received
    December 24, 1996
    Date of Event
    January 1, 1996
    Report Date
    December 23, 1996
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FALLOPOSCOPE DISSECTED THE FALLOPIAN TUBE DURING A FALLOPOSCOPY PROCEDURE. THIS IS AN ANTICIPATED ADVERSE EVENT AS INDICATED IN THE PRODUCT LABELING. * THE ADVERSE EVENT IS MARKED "OTHER" BECAUSE IT IS UNKNWON AS TO WHETHER THE ADVERSE EVENT RESULTS IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALLOPOSCOPE ENDOSCOPE HEZ CONCEPTUS, INC. FAS002 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other LAPAROSCOPY AND HYSTEROSCOPY PERFORMED| SIMULATANEOUS TO FALLOPOSCOPY