BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2210557 · Received August 10, 2011

    Report

    Report Number
    1625774-2011-00098
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    March 17, 2011
    Report Date
    July 11, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE EVALUATION SINCE THERE WAS NO PRODUCT RETURNED. BASED ON INFORMATION PROVIDED BY THE HEALTH CARE PROVIDERS, IT CANNOT BE DETERMINED IF THE ALLEGED SEVERE REACTION IS DUE TO V.A.C. GRANUFOAM DRESSING, BUT ACCORDING TO THE DOCTOR, A SIMILAR ALLERGIC REACTION WAS EXPERIENCED AT A TIME THAT THE NURSE WAS NOT IN CONTACT WITH OR OTHERWISE EXPOSED TO THE SAME V.A.C. DRESSINGS. FURTHERMORE, THERE WAS NO PRODUCT MALFUNCTION. PER THE KCI QUALITY ENGINEER, IT WAS REPORTED THAT THERE HAVE BEEN NO MANUFACTURING CHANGES TO THE V.A.C. GRANUFOAM PROCESS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: IT WAS ALLEGED THAT WHILE THE NURSE WAS PERFORMING A DRESSING CHANGE, THE NURSE EXPERIENCED AN ALLERGIC REACTION. ON 02 AUG 2011, THE KCI REPRESENTATIVE RECEIVED ADDITIONAL INFORMATION FROM THE DOCTOR WHO STATED THAT THE NURSE EXPERIENCED A SEVERE SYSTEMIC REACTION REQUIRING ADMINISTRATION OF CORTISONE, ANTIHISTAMINE, AND ADRENALINE. THE REACTION HAPPENED WHEN THE NURSE WAS OPENING A BOX OF DRESSINGS AND WHILE SHAPING THE GRANUFOAM USING SCISSORS. THE DOCTOR REPEATED THE SIMULATED EXPOSURE BY REPRODUCING WORK ACTIVITY, INCLUDING CLOTHING AND GLOVES IN A PROTECTED ENVIRONMENT. AFTER SEVERAL MINUTES OF EXPOSURE, THE NURSE EXPERIENCED PERIORAL SYMPTOMS SO THE EXPOSURE WAS STOPPED. NO TREATMENT WAS NECESSARY. AFTER THE NURSE RESUMED NORMAL WORK ACTIVITIES, ANOTHER EPISODE WITH THE SEVERITY INTERMEDIATE BETWEEN THE PREVIOUS TWO HAPPENED. THIS EPISODE AROSE WITHOUT ANY CONTACT WITH V.A.C. DRESSINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM OMP KCI USA, INC. V.A.C. GRANUFOAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention