BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP SPONGES 18 X 18

    MDR report key: 3999602 · Received August 5, 2014

    Report

    Report Number
    MW5037672
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 4, 2014
    Manufacturer
    ALLCARE, INC
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE OF THE LAPS OUT OF THE STERILE PACK FOR THE CESAREAN SECTION WAS DIRTY WITH A BLACK SUBSTANCE ON IT, LIKE SOMEONE STEPPED ON IT. THE ENTIRE 5-PACK OF THOSE LAPS WAS REMOVED FROM THE TABLE. DIAGNOSIS OR REASON FOR USE: LAP SPONGES FOR USE DURING CESAREAN DELIVERY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456356 LAP SPONGES 18 X 18 LAP SPONGES 18 X 18 GDY ALLCARE, INC 21NE02

    Patients

    Seq Age Sex Outcome Treatment
    1