BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPOSE ULC

    MDR report key: 10754893 · Received October 29, 2020

    Report

    Report Number
    10754893
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 14, 2020
    Manufacturer
    COVIDIEN LP
    Product Code
    GDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN LP APPOSE ULC SLIM BODY SKIN STAPLER DID NOT CLOSE COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221110 APPOSE ULC STAPLE, REMOVABLE (SKIN) GDT COVIDIEN LP 8886803712

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Required Intervention