BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE LAP SPONGE

    MDR report key: 18560 · Received December 28, 1994

    Report

    Report Number
    MW1004586
    Event Type
    Injury
    Date Received
    December 28, 1994
    Date of Event
    December 14, 1994
    Report Date
    December 15, 1994
    Manufacturer
    ULTI-MED INTL., INC.
    Product Code
    GDY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING THORACIC SURGERY. ONE 12 X 12 SPONGE WAS BEING USED IN THE CHEST. SPONGE SUDDENLY IGNITED WITH FLAMES WHEN CAUTERY WAS ACTIVATED. SPONGE WAS IMMEDIATELY REMOVED FROM THE CHEST BY THE SURGICAL STAFF AND FLAME WAS EXTINGUISHED. NO APPARENT INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE LAP SPONGE SINGLE USE LAP SPONGE GDY ULTI-MED INTL., INC. 27987

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R