BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABTHERA¿ OPEN ABDOMEN NEGATIVE PRESSURE THERAPY (SYSTEM)

    MDR report key: 7385604 · Received March 30, 2018

    Report

    Report Number
    3009897021-2018-00026
    Event Type
    Injury
    Date Received
    March 30, 2018
    Date of Event
    January 1, 2006
    Report Date
    March 30, 2018
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    PMA / PMN Number
    K083357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED GRAFT INFECTIONS ARE RELATED TO V.A.C.® THERAPY. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE STATES: INFECTED WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NON-INFECTED WOUNDS, DEPENDENT UPON FACTORS SUCH AS WOUND CONDITIONS, TREATMENT GOALS. REFER TO DRESSING APPLICATION INSTRUCTIONS FOR DETAILS REGARDING DRESSING CHANGE FREQUENCY. AS WITH ANY WOUND TREATMENT, CLINICIANS AND PATIENTS/CAREGIVERS SHOULD FREQUENTLY MONITOR THE PATIENT'S WOUND, PERIWOUND TISSUE AND EXUDATE FOR SIGNS OF INFECTION, WORSENING INFECTION, OR OTHER COMPLICATIONS. SOME SIGNS OF INFECTION ARE FEVER, TENDERNESS, REDNESS, SWELLING, ITCHING, RASH, INCREASED WARMTH IN THE WOUND OR PERIWOUND AREA, PURULENT DISCHARGE OR STRONG ODOR. INFECTION CAN BE SERIOUS, AND CAN LEAD TO COMPLICATIONS SUCH AS PAIN, DISCOMFORT, FEVER, GANGRENE, TOXIC SHOCK, SEPTIC SHOCK AND/OR FATAL INJURY. SOME SIGNS OR COMPLICATIONS OF SYSTEMIC INFECTION ARE NAUSEA, VOMITING, DIARRHEA, HEADACHE, DIZZINESS, FAINTING, SORE THROAT WITH SWELLING OF THE MUCUS MEMBRANES, DISORIENTATION, HIGH FEVER, REFRACTORY AND/OR ORTHOSTATIC HYPOTENSION OR ERYTHRODERMA (A SUNBURN-LIKE RASH). IF THERE ARE ANY SIGNS OF THE ONSET OF SYSTEMIC INFECTION OR ADVANCING INFECTION AT THE WOUND SITE, CONTACT THE TREATING PHYSICIAN IMMEDIATELY TO DETERMINE IF V.A.C.® THERAPY SHOULD BE DISCONTINUED. DRESSING CHANGES WOUNDS BEING TREATED WITH THE V.A.C.® THERAPY SYSTEM SHOULD BE MONITORED ON A REGULAR BASIS. IN A MONITORED, NON-INFECTED WOUND, V.A.C.® DRESSINGS SHOULD BE CHANGED EVERY 48-72 HOURS, BUT NO LESS THAN 3 TIMES A WEEK, WITH FREQUENCY ADJUSTED BY THE CLINICIAN AS APPROPRIATE. INFECTED WOUNDS MUST BE MONITORED OFTEN AND VERY CLOSELY. FOR THESE WOUNDS, DRESSINGS MAY NEED TO BE CHANGED MORE OFTEN THAN 48-72 HOURS; THE DRESSING CHANGING INTERVALS SHOULD BE BASED ON A CONTINUING EVALUATION OF THE WOUND CONDITION AND THE PATIENT¿S CLINICAL PRESENTATION, RATHER THAN A FIXED SCHEDULE. MAINTAINING A SEAL -FOR DELICATE PERIWOUND TISSUE OR IN AREAS THAT ARE DIFFICULT TO DRESS, APPLY PROTECTIVE SKIN PREPARATION AND FRAME THE WOUND WITH TRANSPARENT FILM OR HYDROCOLLOID DRESSING OR OTHER APPROPRIATE BARRIER. -POSITION THE DRESSING TUBING ON FLAT SURFACES AND AWAY FROM THE PERINEAL AREA, BONY PROMINENCES OR PRESSURE AREAS.

    Description of Event or Problem · 1

    ON MAR 1 2018, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI AFTER A REVIEW OF JOURNAL ARTICLE, STEFAN ACOSTA ARNE SETERNES, MAARIT VENERMO, LEENA VIKATMAA, KARL SORELIUS, ANDERS WANHAINEN, MATS SVENSSON, KHATEREH DJAVANI, MARIN BJORCK. OPEN ABDOMEN THERAPY WITH VACUUM AND MESH MEDIATED FASCIAL TRACTION AFTER AORTIC REPAIR; AN INTERNATIONAL MULTICENTRE STUDY, EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, VOLUME 54, ISSUE 6, 697 - 705 THAT REPORTED THE PURPOSE OF THE STUDY WAS TO ANALYZE THE PRIMARY DELAYS FASCIAL CLOSURE RATED AND COMPLICATIONS AFTER OPEN THERAPY WITH VACUUM AND MESH FASCIAL TRACTION (VACM) AFTER AORTIC REPAIR AND TO COMPARE OUTCOMES BETWEEN THOSE TREATED WITH OPEN ABDOMEN AFTER PRIMARY VERSUS SECONDARY OPERATION. RESULTS FROM THE STUDY REPORTED THAT SEVEN PATIENTS DEVELOPED A GRAFT INFECTION. THE PATIENTS INCLUDED IN THIS STUDY WERE FOLLOWED FROM 2006-2015 AT A TOTAL OF TEN DIFFERENT CENTERS LOCATED IN THE FOLLOWING COUNTRIES: (B)(6) AND SCANDINAVIA. IT IS UNKNOWN WHEN AND IN WHICH COUNTRIES THE EVENTS OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. THE UNIT SERIAL NUMBERS WERE NOT PROVIDED AND UNAVAILABLE FOR RETURN, THEREFORE A DEVICE EVALUATION COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229605 ABTHERA¿ OPEN ABDOMEN NEGATIVE PRESSURE THERAPY (SYSTEM) OMP OMP KINETIC CONCEPTS, INC. WNDABT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other