BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    00162 A-V IMPAD RIGID SOLE FOOTCOVER

    MDR report key: 1309477 · Received December 10, 2008

    Report

    Report Number
    1282497-2008-00030
    Event Type
    Malfunction
    Date Received
    December 10, 2008
    Report Date
    October 20, 2008
    Manufacturer
    NOVAMEDIX, NSL / ORTHOFIX S.R.L.
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 12/10/2008. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULT WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN IN 2008, THAT A CUSTOMER HAD AN ISSUE WITH AN A-V IMPAD. THE CUSTOMER STATED THEY HAD A PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 00162 A-V IMPAD RIGID SOLE FOOTCOVER AV FOOT PUMP JOW NOVAMEDIX, NSL / ORTHOFIX S.R.L. 5065 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN