BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2707371 · Received August 16, 2012

    Report

    Report Number
    2936999-2012-00364
    Event Type
    Injury
    Date Received
    August 16, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 20, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS CURRENTLY IN TRANSIT TO THE MFG PLANT FOR ANALYSIS. US PRODUCT ID# (B)(4) / 510K# K873461.

    Description of Event or Problem · 1

    CUSTOMER STATES A DOCTOR FOUND THE DOUBLE CUFFS MIGHT HAVE A PIN HOLE. THE CALLER CONFIRMED THAT RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT LASER FLEX CUFFED BTR COVIDIEN, FORMERLY TYCO HEALTHCARE 2010103227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention