BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVENA PLUS INCISION MANAGEMENT SYSTEM

    MDR report key: 12526759 · Received September 24, 2021

    Report

    Report Number
    3009897021-2021-00235
    Event Type
    Injury
    Date Received
    September 24, 2021
    Date of Event
    August 26, 2021
    Report Date
    November 2, 2021
    Manufacturer
    KINETIC CONCEPTS, INC
    Product Code
    OMP
    PMA / PMN Number
    K153199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR-3009897021-2021-00235 SUBMITTED ON 24-SEP-2021 NOTED THE FOLLOWING: B5 DESCRIBE EVENT OR PROBLEM: A DEVICE HISTORY RECORD REVIEW OF PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM KIT LOT NUMBER 9183889V001 IS PENDING COMPLETION. CORRECTION A DEVICE HISTORY RECORD REVIEW OF PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM LOT NUMBER 8942891 IS PENDING COMPLETION. G4 PREMARKET IDENTIFICATION PMA/510(K): K180855 CORRECTION K153199. SECTION H3: OTHER (CODE UNSPECIFIED, DESCRIBE IN H10): THE DEVICE WAS DISCARDED. BASED ON THE CORRECTIONS AND ADDITIONAL INFORMATION PROVIDED REGARDING THE DEVICE, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED BLEEDING EVENT IS RELATED TO THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM. IT IS UNKNOWN IF AND WHAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO RESOLVE THE BLEEDING. MULTIPLE UNSUCCESSFUL ATTEMPTS FOR ADDITIONAL CLINICAL INFORMATION WERE MADE. THE DEVICE MET SPECIFICATIONS FOR ALL END RELEASE TESTING OF PRODUCT AND PACKAGING. A DEVICE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE FAMILY AIDE: THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM WAS DISCARDED. ON (B)(6) 2021, A DEVICE HISTORY RECORD REVIEW FOR THE PREVENA PLUS¿ SYSTEM LOT NUMBER 8942891 WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE PREVENA PLUS¿ SYSTEM WAS DISCARDED, THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED BLEEDING EVENT IS RELATED TO THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM. IT IS UNKNOWN IF AND WHAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. MULTIPLE UNSUCCESSFUL ATTEMPTS FOR ADDITIONAL CLINICAL AND DEVICE INFORMATION WERE MADE. A DEVICE EVALUATION IS CURRENTLY PENDING RETURN OF THE DEVICE. A DEVICE HISTORY RECORD REVIEW IS PENDING COMPLETION. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM WILL NOT BE EFFECTIVE IN ADDRESSING COMPLICATIONS ASSOCIATED WITH: ISCHEMIA TO THE INCISION OR INCISION AREAS, UNTREATED OR INADEQUATELY TREATED INFECTION, INADEQUATE HEMOSTASIS OF THE INCISION, CELLULITIS OF THE INCISION AREA. CONTRAINDICATIONS: THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM SHOULD NOT BE USED TO TREAT OPEN OR DEHISCED SURGICAL WOUNDS. THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM SHOULD BE USED WITH CAUTION IN THE FOLLOWING PATIENTS: PATIENTS WITH FRAGILE SKIN SURROUNDING THE INCISION AS THEY MAY EXPERIENCE SKIN OR TISSUE DAMAGE UPON REMOVAL OF THE PREVENA¿ DRESSING. PATIENT WHO ARE AT INCREASED RISK OF BLEEDING FROM THE INCISION ASSOCIATED WITH THE USE OF ANTICOAGULANTS AND/OR PLATELET AGGREGATION INHIBITORS. WARNINGS: BLEEDING: BEFORE APPLYING THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM TO PATIENTS WHO ARE AT RISK OF BLEEDING COMPLICATIONS DUE TO THE OPERATIVE PROCEDURE OR CONCOMITANT THERAPIES AND/OR CO-MORBIDITIES, ENSURE THAT THE HEMOSTASIS HAS BEEN ACHIEVED AND ALL TISSUE PLANES HAVE BEEN APPROXIMATED. IF ACTIVE BLEEDING DEVELOPS SUDDENLY OR IN LARGE AMOUNTS DURING THERAPY, OR IF FRANK BLOOD IS SEEN IN THE TUBING OR IN THE CANISTER, THE PATIENT SHOULD LEAVE THE PREVENA¿ DRESSING IN PLACE, TURN OFF THE THERAPY UNIT AND SEEK IMMEDIATE EMERGENCY MEDICAL ASSISTANCE.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S AIDE: THE PREVENA PLUS ¿ 150 ML CANISTER WAS FULL. THE DRAINAGE WAS ALLEGEDLY DESCRIBED AS BRIGHT RED, AND WAS ALSO COMING OUT FROM THE PREVENA ¿ INCISION DRESSING. NO ADDITIONAL CLINICAL OR DEVICE INFORMATION WAS PROVIDED. A DEVICE HISTORY RECORD REVIEW OF PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM KIT LOT NUMBER 9183889V001 IS PENDING COMPLETION. A DEVICE EVALUATION OF THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM IS PENDING RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422003 PREVENA PLUS INCISION MANAGEMENT SYSTEM OMP OMP KINETIC CONCEPTS, INC WNDPPL 8942891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other