BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12652372 · Received October 18, 2021

    Report

    Report Number
    3009897021-2021-00248
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    September 15, 2021
    Report Date
    January 17, 2022
    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

    BASED ON THE ADDITIONAL INFORMATION REGARDING THE DEVICE, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED EVENTS ARE RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. KCI HAS MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION. THE DEVICE PASSED QUALITY CONTROL CHECKS BEFORE AND AFTER PATIENT PLACEMENT.

    Description of Event or Problem · 0

    ON 04-JAN-2022, A DEVICE EVALUATION WAS COMPLETED FOR THE DEVICE. ON 30-AUG-2021, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A KCI SERVICE CENTER, AND THE DEVICE PASSED AND MET SPECIFICATION. ON (B)(6) 2021, THE DEVICE WAS PLACED WITH THE PATIENT. ON 13-DEC-2021, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED WOUND INFECTION AND SUBSEQUENT PROCEDURE ARE RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. KCI HAS MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION. A DEVICE EVALUATION OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM IS PENDING RETURN OF THE DEVICE. 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 AND 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. OSTEOMYELITIS: V.A.C.® THERAPY SHOULD NOT BE INITIATED ON A WOUND WITH UNTREATED OSTEOMYELITIS. CONSIDERATION SHOULD BE GIVEN TO THOROUGH DEBRIDEMENT OF ALL NECROTIC, NON-VIABLE TISSUE, INCLUDING INFECTED BONE (IF NECESSARY), AND APPROPIATE ANTIBIOTIC THERAPY. PROTECT INTACT BONE WITH A SINGLE LAYER OF NON-ADHERENT MATERIAL.

    Description of Event or Problem · 1

    ON 20-SEP-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2021, THE PATIENT WAS READMITTED INTO THE HOSPITAL ALLEGEDLY DUE TO A WOUND INFECTION. IT IS UNKNOWN WHEN THE INFECTION STARTED, AND IS CURRENTLY USING A HOSPITAL VAC. THE PATIENT STATED THE PHYSICIAN PERFORMED A PROCEDURE INVOLVING SKIN AND MUSCLE TO IN ORDER TO SPEED UP THE HEALING OF THE WOUND. NO ADDITIONAL INFORMATION WAS PROVIDED. A DEVICE EVALUATION FOR THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM IS PENDING RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546350 ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDARM 00849554005600

    Patients

    Seq Age Sex Outcome Treatment
    1 110 YR Male Hospitalization| R