BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVENA¿ INCISION MANAGEMENT SYSTEM

    MDR report key: 19661621 · Received July 2, 2024

    Report

    Report Number
    3009897021-2024-00038
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 15, 2024
    Report Date
    July 2, 2024
    Manufacturer
    KINETIC CONCEPTS, INC
    Product Code
    OMP
    PMA / PMN Number
    K150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED POST-OP WOUND INFECTION IS RELATED TO THE PREVENA¿ INCISION MANAGEMENT SYSTEM. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE FOR ADDITIONAL CLINICAL AND DEVICE INFORMATION. IT IS UNKNOWN IF AND WHAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. 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 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 INFECTION DEVELOPS, PREVENA¿ THERAPY SHOULD BE DISCONTINUED UNTIL THE INFECTION IS TREATED. THE PREVENA¿ INCISION MANAGEMENT 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. 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 17-JUN-2024, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE PHYSICIAN: "WE HAVE BEEN USING THE PREVENA REGULARLY IN OUR POST OP BOWEL PATIENTS AND THEY HAVE GENERALLY BEEN DOING WELL. WE HAVE HAD TWO WOUND INFECTIONS, HOWEVER, BOTH WERE WOMEN WITH BMI GREATER THAN 40, LONG SURGERIES." NO ADDITIONAL INFORMATION AVAILABLE. THE PREVENA¿ INCISION MANAGEMENT SYSTEM LOT NUMBER WAS NOT PROVIDED AND WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION AND DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE ALLEGED POST-OP WOUND INFECTION FOR PATIENT 1 IS REPORTED UNDER MDR-3009897021-2024-00038. THE ALLEGED POST-OP WOUND INFECTION FOR PATIENT 2 IS REPORTED UNDER MDR-3009897021-2024-00039.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506869 PREVENA¿ INCISION MANAGEMENT SYSTEM NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP KINETIC CONCEPTS, INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other