BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    MDR report key: 11961149 · Received June 8, 2021

    Report

    Report Number
    3009897021-2021-00140
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    May 10, 2021
    Report Date
    July 27, 2021
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00849554005600
    PMA / PMN Number
    K201571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    3009897021-2021-00140 SUBMITTED ON 08-JUN-2021 NOTED THE FOLLOWING: SECTION G4 PREMARKET IDENTIFICATION PMA/510(K): K133276. CORRECTION: SECTION G4 PREMARKET IDENTIFICATION PMA/510(K): K201571. BASED ON THE ADDITIONAL INFORMATION PROVIDED REGARDING THE DEVICE, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. THE DEVICE PASSED QUALITY CONTROL CHECKS BEFORE PATIENT PLACEMENT.

    Description of Event or Problem · 0

    ON 30-JUN-2021, A DEVICE EVALUATION WAS COMPLETED BY QUALITY ENGINEERING. ON 25-NOV-2020, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2021, THE DEVICE WAS PLACED WITH THE PATIENT. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. KCI HAS MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION. 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 (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 12-MAY-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S MOTHER: ON (B)(6) 2021, THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS STOPPED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO POSSIBLE OSTEOMYELITIS. NO ADDITIONAL INFORMATION WAS AVAILABLE. ON 01-JUN-2021, A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® WHITEFOAM¿ DRESSING LOT NUMBER WF20036L1V003 WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. A DEVICE EVALUATION OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM IS CURRENTLY PENDING COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858332 ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDARM WF20036L1V003 00849554005600

    Patients

    Seq Age Sex Outcome Treatment
    1 111 YR Hospitalization