BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCAR

    MDR report key: 3972986 · Received July 29, 2014

    Report

    Report Number
    MW5037534
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 22, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TROCAR WAS LABELED AS 12X100MM ON THE PACKAGE, BUT IT WAS SMALLER (10? OR 11?). PACKAGING BELIEVED TO BE INCORRECT. NO HARM TO PATIENT. REMOVED FROM SERVICE. MANUFACTURER: PLEASE NOTE THAT WE DO NOT SENT PRODUCTS TO THE MANUFACTURER, BUT YOU MAY ARRANGE FOR PICK-UP BY CALLING MY NUMBER BELOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441619 TROCAR TROCAR GCJ APPLIED MEDICAL CTR73 1212197

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention