BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX

    MDR report key: 7484197 · Received May 3, 2018

    Report

    Report Number
    MW5077001
    Event Type
    Injury
    Date Received
    May 3, 2018
    Date of Event
    January 26, 2018
    Report Date
    May 1, 2018
    Manufacturer
    ARTHREX
    Product Code
    FWL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD ELECTIVE LAP. CHOLE. AFTER SURGERY, NOTED SMALL BREAK IN SKIN RT. LOWER QUADRANT OF ABDOMEN 2CM X 2CM AS WELL AS ERYTHEMATOUS. STAFF UNABLE TO DETERMINE IF RELATED TO FRICTION OF MOVEMENT OF TROCAR OR RELATED TO TEMPERATURE OF CAMERA LIGHT THAT WAS TOUCHING SKIN. ANTIBIOTIC OINTMENT APPLIED AND DRY STERILE DRESSING. WOUND DID NOT HEAL ACCORDINGLY. ACCORDING TO PATIENT, WOUND DID NOT HEAL. SHE THEN SAW A WOUND CARE PHYSICIAN AND HAD AN EXCISION OF CHRONIC NONHEALING ABDOMINAL WOUND. DIAGNOSED WITH FULL-THICKNESS BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327360 ARTHREX LAP. CAMERA, ENDOSCOPIC FWL ARTHREX AR3200-0020

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention