BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOBLVAC PORTABLE WOUNDCARE

    MDR report key: 1833050 · Received September 2, 2010

    Report

    Report Number
    1419185-2010-15236
    Event Type
    Death
    Date Received
    September 2, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 2, 2010
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    PMA / PMN Number
    K081185
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO OMC. THE DEVICE WAS INSPECTED IN THE "AS FOUND" CONDITION UPON RECEIPT VISUALLY FOR SIGNS OF DAMAGE AND PERFORMANCE TESTING WAS CONDUCTED PER THE RELEASE CRITERIA. THE DEVICE MET ALL ESTABLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    OMC WAS NOTIFIED BY THEIR DISTRIBUTOR THAT A PATIENT WHO WAS PREVIOUSLY RECEIVING WOUND TREATMENT DIED AFTER BEING TRANSFERRED FROM THE NURSING HOME ON (B)(6)2010 TO A HOSPITAL (WHERE HE LATER EXPIRED ON (B)(6)2010). THE PATIENT WAS NOT TRANSFERRED TO THE HOSPITAL WITH THE DEVICE AND THE DEVICE, OR SIMILAR DEVICE, WAS NOT USED AFTER HE WAS TRANSFERRED. THE NURSING HOME REPORTED THAT THE DEVICE WAS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBLVAC PORTABLE WOUNDCARE NEGATIVE WOUND PRESSURE DEVICE BTA OHIO MEDICAL CORPORATION NPT101009

    Patients

    Seq Age Sex Outcome Treatment
    1 80-90 Death