BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPARATOMY SPONGE

    MDR report key: 2092477 · Received May 10, 2011

    Report

    Report Number
    2092477
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 10, 2011
    Manufacturer
    AMD RITMED
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    HAIR FOUND INSIDE STERILE LAPAROTOMY SPONGE PACK DURING OR SET-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPARATOMY SPONGE SPONGE, LAPARATOMY GDY AMD RITMED 1515 60692

    Patients

    Seq Age Sex Outcome Treatment
    1 *