BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KCI® NPWT GAUZE DRESSING

    MDR report key: 6047250 · Received October 21, 2016

    Report

    Report Number
    3009897021-2016-00089
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 29, 2016
    Report Date
    November 21, 2016
    Manufacturer
    KCI USA,INC.
    Product Code
    OMP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION OBTAINED REGARDING THE DEVICE, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ANAPHYLACTIC REACTION IS RELATED TO KCI® NPWT GAUZE DRESSING. IT IS UNKNOWN IF THE PATIENT HAD A KNOWN PRIOR HISTORY OF AN ALLERGY TO PHMB.

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ANAPHYLACTIC REACTION IS RELATED TO KCI NPWT GAUZE DRESSING. THE FOREIGN MATERIAL IS PENDING RETURN TO KCI FOR IDENTIFICATION; THEREFORE, AT THIS TIME, KCI IS UNABLE TO CONFIRM ITS IDENTITY. IT IS UNKNOWN IF THE PATIENT HAD A KNOWN PRIOR HISTORY OF AN ALLERGY TO PHMB. DEVICE LABELING, AVAILABLE IN PRINT STATES: CONTRAINDICATIONS THE USE OF NEGATIVE PRESSURE WOUND THERAPY (NPWT) IS CONTRAINDICATED FOR: -SENSITIVITY TO POLYHEXAMETHYLENE BIGUANIDE (PHMB) (KERLIX AMD ANTIMICROBIAL). WARNINGS: SENSITIVITY TO PHMB: THE KERLIX AMD SUPER SPONGES CONTAIN PHMB, WHICH MAY PRESENT A RISK OF AN ADVERSE REACTION IN PATIENTS WHO ARE ALLERGIC OR HYPERSENSITIVE TO PHMB. IF A PATIENT HAS A KNOWN ALLERGY OR HYPERSENSITIVITY TO PHMB, DO NOT USE KCI NPWT GAUZE DRESSINGS. IF ANY SIGNS OF ALLERGIC REACTION OR HYPERSENSITIVITY DEVELOP, SUCH AS REDNESS, SWELLING, RASH, URTICARIA OR SIGNIFICANT PRURITIS, DISCONTINUE USE AND CONSULT A PHYSICIAN IMMEDIATELY. IF BRONCHOSPASM OR MORE SERIOUS SIGNS OF ALLERGIC REACTION APPEAR, SEEK IMMEDIATE MEDICAL ASSISTANCE.

    Description of Event or Problem · 1

    THE KCI® NPWT GAUZE DRESSING WAS RECEIVED IN KCI QUALITY ENGINEERING ON (B)(6) 2016 AND WAS INSPECTED. THE GAUZE DRESSING WAS RETURNED IN THE ORIGINAL PACKAGING AND NO FAULT WAS FOUND WITH THE PRODUCT. REVIEW OF THE BIOCOMPATIBILITY DOCUMENTS SHOW THAT THE GAUZE DRESSING HAS BEEN TESTED AND CONFORMS TO THE BIOCOMPATIBILITY STANDARDS SET BY ISO 10993-5, 10993-10, 10993-11, AND 10993-12.

    Description of Event or Problem · 1

    ON SEP 29 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: A MALE PATIENT WITH A DEEP PRESSURE ULCER ALLEGEDLY EXPERIENCED A SEVERE ALLERGIC REACTION/ANAPHYLACTIC TYPE REACTION WHEN THE V.A.C. ANTIMICROBIAL GAUZE WAS INSERTED INTO THE PATIENT'S WOUND. THE PATIENT SYMPTOMS BEGAN "ALMOST IMMEDIATELY" WITHIN 20 MINUTES POST GAUZE PLACEMENT. THE SYMPTOMS BEGAN AS SNEEZING, THEN ITCHING, TINGLING SWOLLEN LIPS, NAUSEA, PAINFUL THROAT AND BREATHING. THE PATIENT'S SYMPTOMS PARTIALLY "SETTLED" WITH ADMINISTRATION OF AN ANTIHISTAMINE. EMERGENCY SERVICES WERE CALLED, BUT UPON THEIR ARRIVAL, AN HOUR LATER, THE PATIENT'S VITAL SIGNS HAD IMPROVED AND HE WAS FEELING BETTER. HE WAS ABLE TO BREATH AND SPEAK "OK." NO ADRENALINE WAS REQUIRED BUT THE PATIENT WAS TAKEN TO THE HOSPITAL AS A PRECAUTION. IT WAS ALLEGED THAT THE POLYHEXAMETHYLENE BIGUANIDE (PHMB) FROM THE ANTIMICROBIAL GAUZE WAS THE CAUSE OF THIS EVENT. NO ADDITIONAL INFORMATION WILL BE PROVIDED. A DEVICE HISTORY REVIEW OF LOT NUMBER 2861141 BY KC QUALITY ENGINEERING DETERMINED THAT ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. A DEVICE EVALUATION OF THE KCI NPWT GAUZE DRESSING IS CURRENTLY PENDING COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699075 KCI® NPWT GAUZE DRESSING OMP OMP KCI USA,INC. NA 2861141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention