BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-SORB GAUZE SPONGE 4X4, 16 PLY

    MDR report key: 2143196 · Received June 20, 2011

    Report

    Report Number
    2143196
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDLINE
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF WERE STOCKING THEIR ROOMS AND NOTED THAT A BOX OF GAUZE SPONGES WAS SEALED, BUT COMPLETELY EMPTY. THERE SHOULD BE TEN SPONGES IN THE BOX. THIS ONE HAD NONE. NO PATIENTS WERE INVOLVED IN THIS EVENT AND NO HARM OCCURRED. NO OTHER BOXES OF SPONGES HAD THIS ISSUE. THE MANUFACTURER HAS BEEN CONTACTED AND WE ARE AWAITING THEIR RESPONSE.====================== MANUFACTURER RESPONSE FOR GAUZE SPONGES, ACCU-SORB GAUZE SPONGE 4X4, 16 PLY (PER SITE REPORTER)======================WE ARE AWAITING THE MANUFACTURER'S RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-SORB GAUZE SPONGE 4X4, 16 PLY GAUZE SPONGES GDY MEDLINE * AQ4504906433

    Patients

    Seq Age Sex Outcome Treatment
    1 *