BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3032444 · Received March 29, 2013

    Report

    Report Number
    3009897021-2013-00028
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 27, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN (B)(6) 2008, THE PT WAS DIAGNOSED WITH MALIGNANT HISTIOCYTOMA. THE PHYSICIAN REPORTED THAT THE PRIMARY SITE WAS THE SMOOTH MUSCLE OF THE UPPER EXTREMITIES. FURTHERMORE, THE PT'S CANCER HAD METASTASIZED TO THE LIVER, LUNGS, AND INTESTINE. THE PT BEGAN RECEIVING CHEMOTHERAPY IN 2009. ON (B)(6) 2013, THE PT BEGAN VOTRIENT CHEMOTHERAPY. THE PHYSICIAN NOTED THAT AS THE TREATMENT BEGAN, THE PT EXPERIENCED NAUSEA AND VOMITING. THE PHYSICIAN REPORTED THAT THE PT'S EMESIS CAUSED A SUDDEN INCREASE IN THE PT'S ABDOMINAL PRESSURE, THEREBY CAUSING THE INTESTINAL DEHISCENCE. HOWEVER, THE PHYSICIAN COULD NOT RULE OUT THE POSSIBLE CAUSAL RELATIONSHIP WITH V.A.C. THERAPY. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED INTESTINAL DEHISCENCE AND HEMORRHAGIN ARE RELATED TO V.A.C. THERAPY. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: V.A.C. THERAPY IS CONTRAINDICATED FOR PTS WITH: MALIGNANCY IN THE WOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE KCI (B)(4) REP: ON (B)(6) 2013, THE PHYSICIAN REPORTED THAT THE PT VOMITED AND THAT BLOODY DRAINAGE, AMOUNT UNK, WAS OBSERVED INSIDE THE CANISTER. V.A.C. THERAPY WAS DISCONTINUED. THE PHYSICIAN REPORTED THAT THE INTESTINAL WALL HAD DEHISCED IN FOUR LOCATIONS. THE PT WAS TAKEN TO THE OPERATING ROOM WHERE A TUBE WAS INSERTED INTO ONE PORTION OF THE INTESTINE. THE REMAINING PORTIONS OF THE INTESTINE SHOWED NO DAMAGE, AND THE HEMORRHAGING CEASED. ON (B)(6) 2013, NO DETERIORATION OF THE PT'S CONDITION WAS OBSERVED. ON (B)(6) 2013, THE PHYSICIAN REPORTED THAT THE PT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130167 V.A.C. THERAPY OMP KCI USA INC. V.A.C. ATS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R