BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1813762 · Received August 17, 2010

    Report

    Report Number
    2936999-2010-01099
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 21, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE UNITED STATES. APPLICABLE 510K# FOR THE UNITED STATES DISTRIBUTED PART IS K871204. THE CUSTOMER INDICATED THAT THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE SAMPLE ANALYSIS, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE CUFF BROKE DURING PATIENT USE PREVENTING THE CUFF FROM INFLATING. THIS REPORT IS THE SECOND OCCURRENCE ASSOCIATED TO MFR# 2936999-2010-01098 / (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT 7.5MM LO CONTOUR MURPHY 86083 X10 BTR COVIDIEN, FORMERLY TYCOHEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention