BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-SORB XRAY DETECTABLE USP TYPE VII GAUZE

    MDR report key: 3248799 · Received July 25, 2013

    Report

    Report Number
    3248799
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 25, 2013
    Manufacturer
    MEDLINE INC
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL CASE SET UP, THE SCRUB OBSERVED SPONGE THREADS FRAYING APART. THE SPONGES WERE REMOVED FROM SET UP PRIOR TO PATIENT ENTERING ROOM. NO PATIENT HARM. THIS IS THE THIRD TIME THIS FACILITY HAS SEEN THIS TYPE OF EVENT WITH THIS PRODUCT WITHIN THE LAST 2 WEEKS.======================MANUFACTURER RESPONSE FOR RAYTEC SPONGES, SPONGE GAUZE XRAY (PER SITE REPORTER).======================REPORTER DOES NOT HAVE THIS INFORMATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348874 ACCU-SORB XRAY DETECTABLE USP TYPE VII GAUZE SPONGE, GAUZE GDY MEDLINE INC * AR4506229277

    Patients

    Seq Age Sex Outcome Treatment
    1 *