BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE GAUZE 4"X4"

    MDR report key: 26560 · Received September 8, 1995

    Report

    Report Number
    26560
    Event Type
    Malfunction
    Date Received
    September 8, 1995
    Date of Event
    August 23, 1995
    Report Date
    September 5, 1995
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSING STAFF REPORT VISIBLE STAINING ON FRESHLY OPENED STERILE GAUZE. AFFECTED PRODUCT APPEARS TO BE LIMITED TO THIS LOT. LOT RECALLED IN HOUSE & SAMPLE SENT TO LAB FOR CULTURE. 9/5 CULTURE REPORTS POSITIVE. ALL GAUZE FROM THE MFRS RECALLED IN HOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE GAUZE 4"X4" GAUZE FRO TILLOTSON HEALTHCARE CORP. 0517

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other