BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAJOR CV PACK

    MDR report key: 21452 · Received April 25, 1995

    Report

    Report Number
    MW1005729
    Event Type
    Other
    Date Received
    April 25, 1995
    Date of Event
    February 24, 1995
    Report Date
    February 24, 1995
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FQP
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, NOTED THAT LIGHT GLOVE WAS TORN. SURGEON AND ASSISTANT RE-GLOVED. LATER DURING THE SAME PROCEDURE, NOTED THAT SECOND LIGHT GLOVE WAS TORN. AGAIN SURGEON AND ASSISTANT RE-GLOVED. ALSO IRRIGATED THE OPERATIVE WOUND. PACKAGING WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAJOR CV PACK DISPOSABLE LIGHT HANDLE COVER FQP BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other