BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEAVER VISITEC

    MDR report key: 17871068 · Received October 4, 2023

    Report

    Report Number
    3014527682-2023-00014
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    September 13, 2023
    Report Date
    October 4, 2023
    Manufacturer
    BEAVER VISITEC INTERNATIONAL
    Product Code
    MDM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INSTRUMENT WIPE INSIDE THE PACK WAS USED FOR SOMETHING IT WAS INTENDED FOR. WITH FURTHER INQUIRY THE USER FACILITY CONFIRMED THE ITEM WAS USED THINKING IT WAS GELFOAM AND WAS LEFT INSIDE THE PATIENT. THE INSTRUMENT WIPE WAS CONTAINED WITHIN A SURGICAL CONVENIENCE KIT. THE GELFOAM WAS ADDED TO THE STERILE FIELD BY THE USER FACILITY AFTER BEING PULLED FROM HOSPITAL SUPPLY. THE GELFOAM WAS NOT PART OF THE CONVENIENCE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329997 BEAVER VISITEC INSTRUMENT WIPE MDM BEAVER VISITEC INTERNATIONAL 585712 22K3135

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention