MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-06 for PERFORMAVE * manufactured by Patterson Medical.
[22082007]
Patient received iontophoresis treatment to r arm 11/09/07. The medication used with the therapy was dexamethazone 4mg/ml. The skin was prepped per manufacturing recommendation. Cleaned under both dispersive and treatment sites with the supplied alcohol prep pad, and allowed to dry. The settings used were 80ma at 4. 0 current. When disposable pad was removed a quarter sized burn was noted. Pt subsequently developed a blister followed by dark green scab formation. The area required sharp debridement on 11/17/07 and treatment with accuzyme. Clinical engineering department assessed the machine and did not identify a malfunction. One of two recent incidents. Unknown lot number, device and packaging was not saved. The machine was returned to the company through the sales rep and all of the current stock of electrodes was switched out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 940107 |
| MDR Report Key | 940107 |
| Date Received | 2007-11-06 |
| Report Date | 2007-11-06 |
| Date Reported to FDA | 2007-11-06 |
| Date Added to Maude | 2007-11-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFORMAVE |
| Generic Name | ELECTRODES, IONTOPHORESIS |
| Product Code | KTB |
| Date Received | 2007-11-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 912317 |
| Manufacturer | PATTERSON MEDICAL |
| Manufacturer Address | 270 REMINGTON BLVD. SUITE C BOLINGBROOK IL 60440 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-06 |