BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLCARE LAP SPONGES

    MDR report key: 16663031 · Received April 3, 2023

    Report

    Report Number
    16663031
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    February 2, 2023
    Report Date
    March 27, 2023
    Manufacturer
    ALLCARE, INC
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FIVE LAPAROTOMY SPONGES WERE ADDED TO THE STERILE FIELD FROM THE PACKAGING; THERE WAS ONLY BLUE PLASTIC IN THE SPONGES AND NO BLUE TAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102224 ALLCARE LAP SPONGES GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY ALLCARE, INC AL1818 21VH06

    Patients

    Seq Age Sex Outcome Treatment
    1 Female