BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3093830 · Received April 30, 2013

    Report

    Report Number
    3009897021-2013-00037
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAMILY MEMBER CLAIMED THAT THE HOME HEALTH AGENCY WAS NOT PERFORMING DRESSING CHANGES CORRECTLY AND THAT THIS ALLEGEDLY MAY HAVE BEEN A CAUSE OR CONTRIBUTION TO THE REPORTED COMPLICATIONS. IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO V.A.C. THERAPY. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADD'L INFO, BUT THERE HAS BEEN NO RESPONSE. KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFO TO ESTABLISH A ROOT CAUSE. NO ADD'L INFO IS AVAILABLE. ON (B)(4) 2013, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2013, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2013, THE DEVICE WAS RETURNED TO KCI FOR EVAL. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT. DEVICE HISTORY REVIEWS OF THE V.A.C. GRANUFOAM DRESSING (LOT NUMBER 223872) AND V.A.C. WHITEFOAM DRESSING (LOT NUMBER WF12033/1) DID NOT IDENTIFY ANY NONCONFORMANCES IN THE MFG OF THESE LOTS RELATED TO THIS EVENT. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING PERFORMANCE MET SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE FOLLOWING INFO WAS REPORTED TO KCI BY THE PATIENT'S FAMILY MEMBER: ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE HOSP FOR A SACRAL WOUND INFECTION WHILE ON V.A.C. THERAPY. THE PATIENT WAS PLACED ON ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187128 V.A.C. THERAPY OMP KCI USA INC. ACTIV.A.C. 2233872& WF12033/1

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R