BEUDAMED
    FDA Adverse Event Other Summary report: N

    00162 A-V IMPAD RIGID SOLE FOOTCOVER

    MDR report key: 2560543 · Received April 26, 2012

    Report

    Report Number
    1017072-2012-00006
    Event Type
    Other
    Date Received
    April 26, 2012
    Report Date
    March 26, 2012
    Manufacturer
    BREQ
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A AVI FOOT CUFF. THE CUSTOMER REPORTS A PT EXPERIENCED A DVT AS A RESULT OF WEARING THE FOOT CUFF. THE CLINICIAN ALSO STATED THAT THE PT WAS PUT ON A HEPARIN DRIP WHICH IS PROTOCOL FOR THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 00162 A-V IMPAD RIGID SOLE FOOTCOVER AVI FOOT CUFF JOW BREQ 5065 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK