PROVANT THERAPY SYSTEM 4201A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-13 for PROVANT THERAPY SYSTEM 4201A manufactured by Regenesis Biomedical, Inc..

Event Text Entries

[19656638] Patient is a (b)(6) male with a wound on his right anterior lower leg of at least 10-years duration. The wound is of unknown origin, but is suspected to represent a venous leg ulcer. The patient has been treated with numerous modalities over the years without complete resolution of the wound. Due to the chronic nature of the wound and concern about the on-going risk for marjolin's ulcer (squamous cell carcinoma arising in a chronic cutaneous wound), surveillance biopsies have been performed on a periodic basis. The patient underwent routine biopsy of the wound bed and wound edges on (b)(6)2011. Samples from the wound bed revealed focal squamous cell carcinoma. No discrete lesions were visible at the time of biopsy, the wound measured 40cm x 7 cm. The patient is scheduled to begin radiation therapy shortly. The patient's wound has been treated with provant over the following time periods: (b)(6) 2007 to (b)(6) 2009; (b)(6) 2010 to (b)(6) 2011. The wound has also recently been treated with dermagraft. The patient has been seen regularly in high risk clinic, with provant prescriptions written at approximately 3-month intervals. Provant has been prescribed for symptomatic treatment of pain associated with wound management, as well as to facilitate wound healing. Diagnosis: malignant transformation of a chronic cutaneous ulcer (marjolin's ulcer). Prescribing clinician does not consider provant to have caused or contributed to the development or course of the squamous cell carcinoma. Clinician states that the development of marjolin's transformation in the >10-year-old lower extremity ulcer of this elderly man is not unanticipated and is attributed to the chronic trauma and chronic scarring associated with his very long-standing intractable ulceration. Manufacturer chooses to report this case notwithstanding the clinician's opinion. The device has been returned for engineering evaluation and found to be within specification. Dose, frequency, & route used: (b)(4). Therapy dates: 41 months discontinuous.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2032108-2011-00001
• MDR Report Key: 2161153
• Report Source: 05
• Date Received: 2011-07-13
• Date of Report: 2011-07-08
• Date of Event: 2011-04-27
• Date Mfgr Received: 2011-06-16
• Device Manufacturer Date: 2007-06-01
• Date Added to Maude: 2011-07-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: RICHARD ISENBERG, MD
• Manufacturer Street: 1435 N. HAYDEN RD.
• Manufacturer City: SCOTTSDALE AZ 85257
• Manufacturer Country: US
• Manufacturer Postal: 85257
• Manufacturer Phone: 4809704970
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROVANT THERAPY SYSTEM
• Generic Name: SHORTWAVE DISTHERMY, NONTHERMAL
• Product Code: ILX
• Date Received: 2011-07-13
• Returned To Mfg: 2011-06-21
• Model Number: 4201A
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: REGENESIS BIOMEDICAL, INC.
• Manufacturer Address: SCOTTSDALE AZ US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2011-07-13