BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C.® DRAPE

    MDR report key: 9572329 · Received January 9, 2020

    Report

    Report Number
    3009897021-2020-00005
    Event Type
    Injury
    Date Received
    January 9, 2020
    Date of Event
    December 6, 2019
    Report Date
    January 9, 2020
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI#) FOR ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM (B)(4): (B)(4). DEVICE MANUFACTURE DATE FOR ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM (B)(4) 19-NOV-2018. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED FUNGAL INFECTION WAS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: V.A.C.® THERAPY SAFETY INFORMATION ALL DISPOSABLE COMPONENTS OF THE V.A.C.® THERAPY SYSTEM ARE FOR SINGLE USE ONLY. 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 (FOUND IN V.A.C.® DRESSING CARTONS) 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. PRECAUTIONS THE V.A.C.® THERAPY SYSTEM WILL NOT BE EFFECTIVE IN ADDRESSING COMPLICATIONS ASSOCIATED WITH THE FOLLOWING: ISCHEMIA TO THE INCISION OR INCISION AREA. UNTREATED OR INADEQUATELY TREATED INFECTION. INADEQUATE HEMOSTASIS OF THE INCISION. CELLULITIS OF THE INCISION AREA.

    Description of Event or Problem · 1

    ON 10-DEC-2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2019, THE V.A.C.® DRAPE ALLEGEDLY CAUSED THE PERIWOUND TO BECOME IRRITATION AND INFECTED. THE PHYSICIAN ORDER TO HOLD THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM AND TREAT THE IRRITATION WITH MEDICATION. ON 16-DEC-2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PERIWOUND DEVELOPED IRRITATION AND POSSIBLE FUNGAL INFECTION. THE PHYSICIAN PRESCRIBED AN ANTIFUNGAL CREAM TO TREAT THE FUNGAL INFECTION. ON (B)(6) 2019, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2019, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2020, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI FIELD SERVICES AND PASSED QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT. THE V.A.C.® GRANUFOAM¿ DRESSING AND DRAPE LOT NUMBERS ARE NOT AVAILABLE, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35671 V.A.C.® DRAPE OMP OMP KINETIC CONCEPTS, INC. VACDSP ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention