BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2230712 · Received August 17, 2011

    Report

    Report Number
    1625774-2011-00100
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 21, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE FILING THIS REPORT DUE TO POTENTIAL USE ERROR CANNOT BE ENTIRELY RULED OUT DUE TO LIMITED INFORMATION PROVIDED. ON (B)(4) 2011, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURES BY KCI FIELD SERVICE EMPLOYEE. THE DEVICE PASSED QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2011, THE UNIT WAS PLACED WITH THE PATIENT. ON (B)(4) 2011, THE UNIT WAS RETURNED TO THE KCI SERVICE CENTER FOR DEVICE EVALUATION. THE UNIT WAS TESTED PER QUALITY CONTROL PROCEDURES. THE DEVICE PASSED QUALITY CONTROL AND MET SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S WIFE: ON (B)(6) 2011, V.A.C. THERAPY WAS INITIATED. ON (B)(6) 2011, THE PATIENT EXPERIENCED BLEEDING. EMERGENCY MEDICAL SERVICES (EMS) ARRIVED AND PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HEMATOMA IN THE PATIENT'S LEFT GROIN WOUND. ADDITIONAL INFORMATION RECEIVED FROM THE HOME HEALTH CLINICAL COORDINATOR ON (B)(4) 2011, THE PATIENT HAD A HEMATOMA PRIOR TO VAC THERAPY. ON (B)(6) 2011, THE HEMATOMA WAS DRAINED, VAC THERAPY STARTED AND THE PATIENT WAS SENT HOME. ON (B)(6) 2011, THE PATIENT WAS SEEN BY THE DOCTOR, INR WAS ELEVATED "HIGH" AND WAS INSTRUCTED TO DECREASE DOSE OF COUMADIN. ON (B)(6) 2011, THE PATIENT'S WIFE CALLED THE HOME HEALTH AGENCY TO REPORT THAT THE PATIENT HAD SEVERE PAIN IN THE LEFT GROIN AND THERE WAS BRIGHT RED BLOOD IN TUBING AND CANISTER WAS FULL. EMS WAS CALLED AND PATIENT WAS ADMITTED TO THE HOSPITAL FOR BLEEDING. BLEEDING WAS STABILIZED AND IT WAS NOTED THAT ANOTHER HEMATOMA HAD DEVELOPED. THE PATIENT REMAINS IN THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R COUMADIN| ASPIRIN| MOTRIN EVERY FOUR HOURS.