BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAI

    MDR report key: 11756 · Received January 25, 1994

    Report

    Report Number
    11756
    Event Type
    Injury
    Date Received
    January 25, 1994
    Date of Event
    September 1, 1993
    Report Date
    October 28, 1993
    Manufacturer
    MAI
    Product Code
    GDY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE NUMBER OF POST-OP INFECTIONS FOR MONTH OF AUGUST WAS INCREASED. THERE WERE 5 POST-OP INFECTIONS. RPTR'S USUAL AMOUNT IS 0-1. DURING THIS TIME RPTR WAS USING LAP SPONGES THAT WERE RECALLED DUE TO NONSTERILITY. HOWEVER, NONE OF THESE INFECTIONS HAD ANY FOREIGN OR RELATED ORGANISM. ALSO ONLY 3 OF THE 5 HAD LAP SPONGES USED DURING PROCEDURE. SEPT AND OCT RATE HAS AGAIN RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAI STERILE LAP SPONGE GDY MAI 100-1434

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization