MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-06-05 for PROVANT WOUND THERAPY SYSTEM 4201 manufactured by Regenesis Biomedical, Inc..
[17728314]
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.
Patient Sequence No: 1, Text Type: D, B5
[17963399]
Conclusions: device operates according to specifications. Device is within calibration. No failure detected. Cause of unusual event unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032108-2008-00001 |
| MDR Report Key | 1057124 |
| Report Source | 05 |
| Date Received | 2008-06-05 |
| Date of Report | 2008-06-05 |
| Date of Event | 2008-05-05 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2008-06-10 |
| 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 NORTH HAYDEN RD. |
| Manufacturer City | SCOTTSDALE AZ 85275 |
| Manufacturer Country | US |
| Manufacturer Postal | 85275 |
| 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 | 2008-06-05 |
| Returned To Mfg | 2008-05-20 |
| 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 | 1024904 |
| Manufacturer | REGENESIS BIOMEDICAL, INC. |
| Manufacturer Address | SCOTTSDALE AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-06-05 |