BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVANT WOUND THERAPY SYSTEM

    MDR report key: 1348842 · Received March 23, 2009

    Report

    Report Number
    2032108-2009-00001
    Event Type
    Injury
    Date Received
    March 23, 2009
    Date of Event
    February 18, 2009
    Report Date
    February 18, 2009
    Manufacturer
    REGENESIS BIOMEDICAL, INC.
    Product Code
    ILX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROVANT DEVICE IS BEING RETURNED TO MANUFACTURER FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A PARAPLEGIC MALE WITH 6-MONTH OLD RECURRENT SACRAL STAGE IV PRESSURE ULCER TREATED WITH PROVANT AND PANAFIL SPRAY IN ADDITION TO BASIC WOUND CARE. DURATION OF THERAPY 13 DAYS (PROVANT) AND >2 MONTHS (PANAFIL). ON DAY 5 OF PROVANT, WIFE REPORTED DEVELOPMENT OF SEVERAL ASYMPTOMATIC 2 CM BLISTERS AROUND THE PERIPHERY OF THE WOUND. PROVANT WAS DISCONTINUED. PATIENT WAS SEEN BY VISITING NURSE 2 WEEKS LATER, AND NO BLISTERS WERE SEEN. PROVANT WAS RESUMED. SIX DAYS LATER, THE PATIENT WAS NOTED TO HAVE MACERATION ABOUT THE WOUND EDGES WITH NON-BLANCHING ERYTHEMA, AND 6-8 SMALL NON-TENDER STAGE II SKIN EROSIONS CONSISTENT WITH DE-ROOFED BLISTERS. PROVANT WAS DISCONTINUED. EIGHT DAYS LATER, THE SKIN SURROUNDING THE WOUND APPEARED NORMAL. CLINICIAN'S DIAGNOSIS WAS PERI-WOUND VESICULAR SKIN REACTION, POSSIBLY DUE TO PROVANT, POSSIBLY A HYPERSENSITIVITY REACTION SECONDARY TO PANAFIL. WOUND CARE INCLUDED ALGINATE DRESSINGS AND TOPICAL MICONAZOLE TO BUTTOCKS. PATIENT HAS BEEN RECEIVING BACTRIM DS SINCE 2008 FOR POSSIBLE OSTEOMYELITIS.

    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 79 YR Other