BEUDAMED
    FDA Adverse Event Summary report: N

    LAPAROTOMY SPONGES

    MDR report key: 3588772 · Received January 8, 2014

    Report

    Report Number
    3588772
    Date Received
    January 8, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 8, 2014
    Manufacturer
    AMD-RITMED
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DR WAS USING A LAP SPONGE ON PATIENT'S RIGHT BREAST AND NOTICE SMALL PIECE OF FIBER FROM LAP SPONGE IN THE WOUND. THE PIECE WAS REMOVED AND SENT TO THE NURSE MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12127 LAPAROTOMY SPONGES GAUZE, SPONGE EFQ AMD-RITMED * 64807

    Patients

    Seq Age Sex Outcome Treatment
    1 *