BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA WOUND VAC

    MDR report key: 2538126 · Received April 11, 2012

    Report

    Report Number
    MW5025036
    Event Type
    Injury
    Date Received
    April 11, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 11, 2012
    Manufacturer
    KCI
    Product Code
    OMP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    KCI VIA UNIT MALFUNCTION CAUSED PROLONGED HOSPITALIZATION AND EXCESSIVE PAIN FOR PT. SUSPECTED PROBLEM WITH DRAPE OCCLUSION INITIALLY, THEN CONNECTED TO STANDARD INFOVAC WHICH WORKED PROPERLY. RECONNECT LATER TO SAME VIA (ONLY ONE AVAILABLE) WITHOUT PROPER FUNCTION. RETURN TO INFOVAC WHICH WORKED PROPERLY. FOLLOWING DAY KCI REP ATTRIBUTED PROBLEM TO DEVICE FAILURE AND SEQUESTERED FOR FURTHER TESTING. VIA IS A NEW PRODUCT AVAILABLE FROM KCI - KINECTIC CONCEPTS INCORPORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIA WOUND VAC VIA OMP KCI 2156182

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R| S