BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2120149 · Received June 3, 2011

    Report

    Report Number
    2936999-2011-00382
    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
    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 MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION 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 PATIENT 3 TIMES ONE AFTER THE OTHER; THE PATIENT DID NOT SUFFER ANY INJURY FROM THE INCIDENT. THIS REPORT IS ASSOCIATED TO THE SECOND OCCURRENCE REPORT ON MFR# 2936999-2011-00316.

    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