BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAPAROSCOPIC INSTRUMENT

    MDR report key: 19696 · Received February 25, 1994

    Report

    Report Number
    2020550-1994-00004
    Event Type
    Other
    Date Received
    February 25, 1994
    Date of Event
    June 16, 1991
    Report Date
    February 2, 1994
    Manufacturer
    UNKNOWN
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ALTHOUGHT IT IS NOT CLEAR IF THE ALLEGEDLY INVOLVED INSTRUMENT IS OURS OR NOT, TO BE ON THE SAFE SIDE, WE ARE REPORTING IT AS AN MDR.WE WERE SERVED WITH A SUMMONS ON JANUARY 28, 1994; ABOUT A YEAR AFTER A HYSTERECTOMY PROCEDURE, IT WAS FOUND THAT A PIECE, IT WAS FOUND THAT A PIECE OF LAPAROSCOPY INSTRUUMENT WAS LEFT INSIDE THE PT UNDETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC INSTRUMENT HET UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other