MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-23 for PROVANT WOUND THERAPY SYSTEM 4201 manufactured by Regenesis Biomedical, Inc..
[18904952]
Provant device is being returned to manufacturer for evaluation, but has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
[18970179]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032108-2009-00001 |
| MDR Report Key | 1348842 |
| Report Source | 05 |
| Date Received | 2009-03-23 |
| Date of Report | 2009-02-18 |
| Date of Event | 2009-02-18 |
| Date Mfgr Received | 2009-02-18 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2009-03-27 |
| 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 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 | 2009-03-23 |
| Model Number | 4201 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REGENESIS BIOMEDICAL, INC. |
| Manufacturer Address | SCOTTSDALE AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-23 |