BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 2871591 · Received December 11, 2012

    Report

    Report Number
    1625774-2012-00079
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED BY THE NURSE, THE PT'S WOUND APPEARED TO BE INFECTED. THE PT WAS PLACED ON ANTIBIOTIC THERAPY. A WOUND CULTURE WAS NOT PERFORMED. THERE WAS NO ALLEGED PRODUCT MALFUNCTION. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFO, BUT THERE HAS BEEN NO RESPONSE. ON (B)(4) 2012, KCI FIELD SERVICE TESTED THE DEVICE PER QUALITY CONTROL (QC) PROCEDURE AND DETERMINED THE UNIT PASSED (QC) CHECKS AND MET SPECIFICATIONS BEFORE PLACEMENT WITH THE PT. ON (B)(6) 2012, THE DEVICE WAS PLACED WITH THE PT. ON (B)(6) 2012, THE SERVICE WORK ORDER FOR THE DEVICE SWAP WAS CANCELLED DUE TO PT REFUSAL THEREFORE THE DEVICE IS NOT AVAILABLE FOR EVALUATION BY KCI QUALITY ENGINEERING. THE DEVICE REMAINS WITH THE PT WITH NO ADDITIONAL REPORTED ISSUE WITH THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE NURSE ALLEGED THE PT'S WOUND WAS INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY OMP KCI USA, INC. ACTIV.A.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other