BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2120125 · Received June 3, 2011

    Report

    Report Number
    2936999-2011-00316
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K965132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER# 107-70 IS NOT DISTRIBUTED IN THE U.S., HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K965132. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR ANALYSIS. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE BALLOON WAS DEFLATING AFTER BEING FITTED ON PT 3 TIMES ONE AFTER THE OTHER; THE PT DID NOT SUFFER ANY INJURY FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT INTERMEDIATE HI-LO TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE 201103209

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention