BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN ENDO GIA 45MM TAN VASCULAR LOAD STAPLER

    MDR report key: 15362690 · Received September 2, 2022

    Report

    Report Number
    MW5111869
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 8, 2022
    Report Date
    August 31, 2022
    Manufacturer
    MEDTRONIC / COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 9 YO F HX OF ACUTE APPENDICITIS MANAGED NONOPERATIVELY FOR CONCURRENT ENTERO/ RHINOVIRUS IN (B)(6) 2022. INTERVAL LAPAROSCOPIC APPENDECTOMY WAS PERFORMED ON (B)(6) 2022. PT READMITTED WITH AN INFECTED HEMATOMA IN RLQ ON (B)(6) 2022 REQUIRING IR DRAINAGE. THE DRAIN WAS REMOVED AND PT WAS DISCHARGED ON (B)(6) 2022. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617335 COVIDIEN ENDO GIA 45MM TAN VASCULAR LOAD STAPLER STAPLE, IMPLANTABLE GDW MEDTRONIC / COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Required Intervention