BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVANT WOUND THERAPY SYSTEM

    MDR report key: 1163051 · Received September 18, 2008

    Report

    Report Number
    2032108-2008-00002
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    March 31, 2007
    Report Date
    September 17, 2008
    Manufacturer
    REGENESIS BIOMEDICAL, INC.
    Product Code
    ILX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICIAN NOTES THAT THERE IS A RECOGNIZED INCIDENCE OF SQUAMOUS CELL CARCINOMA OCCURRING SPONTANEOUSLY WITH CHRONIC PRESSURE ULCERS (KNOWN IN THE LITERATURE AS MARJOLIN'S ULCERS, THOUGHT TO BE DUE TO CHRONIC TISSUE TRAUMA), AND THE MALIGNANCY WAS DIAGNOSED 10 MONTHS AFTER CESSATION OF THERAPY WITH PROVANT. THE CLINICIAN STATES THAT HE CONCLUDES THAT PROVANT DID NOT CAUSE OR CONTRIBUTE TO THE DEVELOPMENT OF THE MALIGNANCY. THE MFR CHOOSES TO REPORT THIS CASE NOT WITHSTANDING THE CLINICIAN'S OPINION. FOLLOWING CESSATION OF THERAPY, THE DEVICE WAS RETURNED TO THE MANUFACTURER IN THE ROUTINE FASHION FOR DECONTAMINATION AND RETURNED TO RENTAL INVENTORY. NO IMMEDIATE INSPECTION WAS PERFORMED SINCE THE CESSATION OF THERAPY WAS NOT ASSOCIATED WITH A COMPLAINT OR ADVERSE EVENT. THE DEVICE WAS ROUTINELY INSPECTED AND FOUND TO BE FULLY WITHIN SPECIFICATION IN 2007.

    Description of Event or Problem · 1

    PATIENT IS LONG-TERM PARAPLEGIC (>50 YEARS) WITH EXTENSIVE HISTORY OF SACRAL, ISCHIAL, HEEL AND KNEE PRESSURE ULCERS REQUIRING EXTENSIVE AND CHRONIC TREATMENT. PATIENT UNDERWENT LEFT HIP DISARTICULATION 30 YEARS AGO FOR PRESSURE ULCERS. PATIENT UNDER CARE AT VARIOUS INSTITUTIONS WITH FREQUENT INTERVAL VISITS. SACRAL, HEEL AND KNEE PRESSURE ULCERS TREATED WITH STANDARD BASIC WOUND CARE FOR MANY YEARS. SACRAL ULCER TREATED ADJUNCTIVELY WITH PROVANT WOUND THERAPY SYSTEM FROM APPROXIMATELY 2005 TO 2007, WITH DOSING REGIMEN DECREASED FROM TWICE DAILY TO ONCE DAILY IN 2006, FOR COMPLIANCE REASONS. THERAPY WAS DISCONTINUED DUE TO POOR COMPLIANCE. PATIENT'S COURSE WAS UNREMARKABLE UNTIL HE PRESENTED FOR ROUTINE EVALUATION IN 2008, AT WHICH TIME A CAULIFLOWER-TYPE LESION WAS NOTED AT THE EDGE OF THE SACRAL PRESSURE ULCER. ULCER MEASURED 8CM X 2.6CM X 2CM. BIOPSY CONFIRMED INVASIVE SQUAMOUS CELL CARCINOMA. THE LESION WAS JUDGED TO BE INOPERABLE AND THE PATIENT WAS TREATED PALLIATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVANT WOUND THERAPY SYSTEM SHORTWAVE DIATHERMY, NON THERMAL ILX REGENESIS BIOMEDICAL, INC. 4201

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization