BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH & NEPHEW, INC

    MDR report key: 335135 · Received May 29, 2001

    Report

    Report Number
    335135
    Event Type
    Injury
    Date Received
    May 29, 2001
    Date of Event
    May 11, 2001
    Report Date
    May 25, 2001
    Manufacturer
    SMITH & NEPHEW INC
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FAN RETRACTOR FAILED DOSE DURING LAPAROSCOPY RESULTING IN A LAPAROTOMY TO REMOVE THE INSTRUMENT. NO LONG TERM PT HARM. LAPAROSCOPY BECAME A LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24905 SMITH & NEPHEW, INC 10MM FAN RETRACTOR GAD SMITH & NEPHEW INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention