BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

    MDR report key: 15728164 · Received November 4, 2022

    Report

    Report Number
    3009897021-2022-00169
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 5, 2022
    Report Date
    November 3, 2022
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    PMA / PMN Number
    K180855
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE OCCURRENCE DATE FOR THE PRIOR INFECTIONS IS UNKNOWN. THEREFORE, THE DATE OF THE MOST RECENT ALLEGED INFECTION WAS UTILIZED. THE PREVENA PLUS¿ SYSTEM LOT NUMBER WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED; THEREFORE A DEVICE EVALUATION AND DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTIONS ARE RELATED TO THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM. ADDITIONALLY, IT IS UNKNOWN IF AND WHAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO MITIGATE THE ALLEGED EVENTS. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL CLINICAL AND DEVICE INFORMATION. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNINGS: INFECTED WOUNDS: 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). SILVER IN THE INTERFACE LAYER OF PREVENA¿ DRESSING IS NOT INTENDED TO TREAT INFECTION, BUT TO REDUCE BACTERIAL COLONIZATION IN THE FABRIC. IF INFECTION DEVELOPS, PREVENA PLUS¿ THERAPY SHOULD BE DISCONTINUED UNTIL THE INFECTION IS TREATED. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A KINETIC CONCEPTS, INC. PRODUCT MALFUNCTIONED, IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2022, THE PATIENT UNDERWENT KNEE REPLACEMENT SURGERY TO THE LEFT KNEE AND A PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM WAS PLACED. THE PATIENT HAS HAD FOUR PRIOR SURGERIES AND A PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM HAS BEEN PLACED AFTER EACH ONE. THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION AFTER EACH SURGERY DUE TO THE LANYARD STRAP CLIP BREAKING, WHICH THEN CAUSED THE UNITS TO FALL. THE FORCE OF THE FALL DISCONNECTED THE TUBING FROM THE CANISTER, CAUSING A BREACH IN THE SEAL. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PREVENA PLUS¿ SYSTEM LOT NUMBER WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED, THEREFORE A DEVICE EVALUATION AND DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2787521 PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDPPL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other