MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-22 for DUPEL UNK manufactured by Empi.
[18489646]
Patient was treated bilaterally with iontophoresis. This device was used on the left forearm over a meaty area. The same type of electrode was used bilaterally, with 2 different machines. The patient tolerated a dose of 40 ma/min and current of 1. 5 ma on the left. He tolerated 2. 5 ma on the right with a different machine. The patient had no c/o of discomfort during the treatment. When the electrode was removed on the left arm, there was a head of a pin size burn in the center of the placement of the electrode, light brown in color.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 796656 |
| MDR Report Key | 796656 |
| Date Received | 2006-11-22 |
| Date of Report | 2006-11-22 |
| Date of Event | 2006-09-25 |
| Report Date | 2006-11-22 |
| Date Reported to FDA | 2006-11-22 |
| Date Added to Maude | 2006-12-21 |
| 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 | DUPEL |
| Generic Name | STIMULATOR, IONTOPHORESIS |
| Product Code | KTB |
| Date Received | 2006-11-22 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 784209 |
| Manufacturer | EMPI |
| Manufacturer Address | 599 CARDIGAN RD. ST. PAUL MN 55126 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-22 |