BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVANT WOUND THERAPY SYSTEM

    MDR report key: 1057124 · Received June 5, 2008

    Report

    Report Number
    2032108-2008-00001
    Event Type
    Injury
    Date Received
    June 5, 2008
    Date of Event
    May 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    REGENESIS BIOMEDICAL, INC.
    Product Code
    ILX
    PMA / PMN Number
    K972093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DEVICE OPERATES ACCORDING TO SPECIFICATIONS. DEVICE IS WITHIN CALIBRATION. NO FAILURE DETECTED. CAUSE OF UNUSUAL EVENT UNK.

    Description of Event or Problem · 1

    PT TREATED FOR BILATERAL LOWER LEG ISCHEMIC ULCERS USING PROVANT AND PANAFIL IN ADDITION TO BASIC WOUND CARE. DURATION OF THERAPY 12 DAYS AND > 12 DAYS RESPECTIVELY. PT NOTED SKIN IRRITATION AND DISCOMFORT INTERMITTENTLY WITH PANAFIL OINTMENT APPLICATION, ESPECIALLY WHEN OINTMENT SPREAD ONTO ADJACENT SKIN. UPON INITIATION OF PROVANT, PT NOTED PROGRESSIVE BURNING SENSATION ASSOCIATED WITH TREATMENT SESSIONS, INVOLVING ONLY THE RIGHT ANKLE ULCER (AND NOT THE LEFT ANKLE ULCER DESPITE BOTH RECEIVING IDENTICAL THERAPY). DESPITE MEASURABLE IMPROVEMENT IN THE RIGHT AND LEFT LEG ULCERS, BOTH TREATMENTS WERE DISCONTINUED IN 2008, IN RESPONSE TO THE ON-GOING BURNING SYMPTOMS AND PERI-WOUND ERYTHEMA. PT PRESENTED TO ER TWO DAYS LATER DUE TO SEVERE PAIN ABOUT THE RIGHT ANKLE, AND WAS FOUND TO HAVE A SMALL AREA OF BLISTERING AND NECROSIS ADJACENT TO THE WOUND, SUGGESTIVE OF A 3RD DEGREE BURN. THE WOUND WAS DEBRIDED AND TREATED CONSERVATIVELY WITH ANTIBIOTICS. PAIN AND BURN CHANGES RESOLVED OVER SEVERAL DAYS OF ANTIBIOTICS AND BASIC WOUND CARE. THE LEFT LEG ISCHEMIC ULCER HAD BEEN TREATED WITH THE SAME PROVANT DEVICE AND THE SAME PANAFIL OINTMENT TUBE AS THE RIGHT ULCER, BUT NEVER BECAME SYMPTOMATIC NOR EVIDENCED ANY ADVERSE EFFECT. PT CONTINUES TO DO WELL AT 1 MONTH FOLLOW UP.

    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 73 YR Other MORPHINE| FUROSEMIDE| BROMIDE| IPRATOPIUM| HYDROXYSINE| TELFA| HYPAFIX| COLCHICINE| OXYCODONE| CALCIUM| ASA| ALLOPURINOL| MEDS: ALBUTEROL| COMPRESSION| WOUND CARE WITH PANAFIL| SPIRONOLACTONE| DIAZEPAM| FLUNISOLIDE