MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-18 for PROVANT WOUND THERAPY SYSTEM 4201 manufactured by Regenesis Biomedical, Inc..
[18211002]
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.
Patient Sequence No: 1, Text Type: N, H10
[18226887]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032108-2008-00002 |
| MDR Report Key | 1163051 |
| Report Source | 05 |
| Date Received | 2008-09-18 |
| Date of Report | 2008-09-17 |
| Date of Event | 2007-03-31 |
| Date Mfgr Received | 2008-08-18 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2008-09-23 |
| 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 ISCOBERG, MD |
| Manufacturer Street | 1435 NORTH 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 |
| Brand Name | PROVANT WOUND THERAPY SYSTEM |
| Generic Name | SHORTWAVE DIATHERMY, NON THERMAL |
| Product Code | ILX |
| Date Received | 2008-09-18 |
| Returned To Mfg | 2007-06-10 |
| Model Number | 4201 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1192658 |
| Manufacturer | REGENESIS BIOMEDICAL, INC. |
| Manufacturer Address | SCOTTSDALE AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-09-18 |