BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 3131804 · Received April 30, 2013

    Report

    Report Number
    1219930-2013-00341
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Report Date
    April 4, 2013
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: A SURGEON MENTIONED BILE LEAKS AND SAID HE WOULD NOT USE COVIDIEN PRODUCT BECAUSE OF THIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188872 NONE GAM COVIDIEN, FORMERLY US

    Patients

    Seq Age Sex Outcome Treatment
    1