BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPEN HEART PACK

    MDR report key: 83805 · Received April 15, 1997

    Report

    Report Number
    1423537-1997-00062
    Event Type
    Other
    Date Received
    April 15, 1997
    Date of Event
    March 20, 1997
    Report Date
    April 15, 1997
    Manufacturer
    ALLEGIANCE-SURGICAL GROUP
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGIANCE RESPONSE: BATCH HISTORY RECORD REVIEWED FOR ID OF PRODUCTS INVOLVED. NO DEVIATIONS WERE NOTED DURING THE MFG PROCESS. NO ADD'L HANDLING OF THESE COMPONENTS IS DONE DURING ASSEMBLY. SUPPLIERS NOTIFIED. VALLEYLAB INC RESPONSE: A SEARCH OF THE PRODUCT HISTORY WAS PERFORMED FOR THE LOT NUMBER REPORTED AND NO PERTINENT ENTRIES WERE FOUND. NO PRODUCT WAS RETURNED FOR EVAL, THEREFORE NO TESTING COULD BE PERFORMED. JOHNSON & JOHNSON MEDICAL INC (FOR MEDICAL TASK FORCE) RESPONSE: WITHOUT A SAMPLE, A COMPLETE INVESTIGATION IS NOT POSSIBLE. HOWEVER, THIS SPONGE IS COMPOSED OF COTTON AND UNDER CERTAIN CIRCUMSTANCES (HEAT SOURCE AND OXYGEN) WILL IGNITE. COMPLAINTS ARE REVIEWED BY THE MFG SITE AND TRENDS ARE MONITORED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TAKING DOWN THE MAMMARY ARTERY, USING A 4X4 X-RAY SPONGE AND CAUTERY PENCIL, WHEN THE SPONGE CAUGHT FIRE. THE SPONGE WAS THROWN ON THE FLOOR AND AN ASEPTO OF WATER WAS USED TO PUT OUT THE FIRE. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN HEART PACK OPEN HEART PACK GDY ALLEGIANCE-SURGICAL GROUP SCV38OHSW 222057

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other