BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVENA PLUS¿ CUSTOMIZABLE¿ DRESSING

    MDR report key: 7358967 · Received March 21, 2018

    Report

    Report Number
    3009897021-2018-00020
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    February 24, 2018
    Report Date
    March 21, 2018
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED SKIN REACTION IS RELATED TO THE PREVENA PLUS¿ CUSTOMIZABLE¿ DRESSING. WARNINGS ALLERGIC RESPONSE: THE PREVENA PLUS¿ DRESSING HAS AN ACRYLIC ADHESIVE COATING AND A SKIN INTERFACE LAYER WITH SILVER, WHICH MAY PRESENT A RISK OF AN ADVERSE REACTION IN PATIENTS WHO ARE ALLERGIC OR HYPERSENSITIVE TO ACRYLIC ADHESIVES OR SILVER. IF A PATIENT HAS A KNOWN ALLERGY OR HYPERSENSITIVITY TO THESE MATERIALS, DO NOT USE PREVENA¿ INCISION MANAGEMENT SYSTEM. IF ANY SIGNS OF ALLERGIC REACTION, IRRITATION OR HYPERSENSITIVITY DEVELOP, SUCH AS REDNESS, SWELLING, RASH, URTICARIA, OR SIGNIFICANT PRURITUS, PATIENT SHOULD CONSULT A PHYSICIAN IMMEDIATELY. IF BRONCHOSPASM OR MORE SERIOUS SIGNS OF ALLERGIC REACTION APPEAR, THE PATIENT SHOULD TURN OFF THE THERAPY AND SEEK IMMEDIATE EMERGENCY MEDICAL ASSISTANCE.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE CLINICAL RESEARCH NURSE: ON (B)(6) 2018, THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM WAS APPLIED TO THE PATIENT. ON (B)(6) 2018, THE PREVENA PLUS¿ SYSTEM WAS REMOVED, AND THE NURSE ALLEGEDLY OBSERVED RASHES THROUGHOUT THE PATIENT¿S BACK, BUTTOCKS AND RIGHT SIDE OF THE LOWER ABDOMEN WITH AN ITCHY SENSATION REPORTED BY THE PATIENT. THE ANTIHISTAMINE, BENADRYL WAS ADMINISTERED WHICH REPORTEDLY RELIEVED THE ITCHY SENSATION, BUT THE RASHES ALLEGEDLY REMAINED. THE PATIENT REPORTED SHE WAS VERY HOT AND EXPERIENCED SWEATING THE NIGHT BEFORE. ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE CLINICAL RESEARCH NURSE: THE RASH WAS REPORTED AS MINOR, AND THE APPLICATION OF BENADRYL RESOLVED THE ITCHINESS. THE PATIENT DID NOT EXPERIENCE AN ANAPHYLACTIC REACTION AND WAS DISCHARGED HOME 3 DAYS AFTER THE DISCOVERY OF THE RASHES. THE PHYSICIAN CONFIRMED ¿THE RASHES DID NOT SPREAD ANY FURTHER FOR SEVERAL DAYS, AND THERE WAS NEVER ANY THROAT SWELLING OR RESPIRATORY DISTRESS¿¿ NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE CLINICAL RESEARCH NURSE: THE PREVENA PLUS¿ CUSTOMIZABLE¿ DRESSING LOT NUMBER IS NOT AVAILABLE AS IT WAS DISCARDED. THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201809 PREVENA PLUS¿ CUSTOMIZABLE¿ DRESSING OMP OMP KINETIC CONCEPTS, INC. WNDPPL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention