MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-02 for MEDITRODE IONTOPHORETIC DELIVERY ELECTRODE * manufactured by Life-tech Intl., Inc..
[175034]
After removing electrode from medial malleolus - noted 2 areas 1cm in diameter each that appeared darkened. Parameters set at 1. 75 for 40 ma/min. This is second burn. Previous was 12/24/98 with. 5cm red area with blisters. Parameter 2. 5 amp for 40 ma/min. Both healed without problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015876 |
| MDR Report Key | 213902 |
| Date Received | 1999-03-02 |
| Date of Report | 1999-02-26 |
| Date of Event | 1999-02-05 |
| Date Added to Maude | 1999-03-16 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDITRODE IONTOPHORETIC DELIVERY ELECTRODE |
| Generic Name | * |
| Product Code | KTB |
| Date Received | 1999-03-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 3725801 |
| ID Number | 6560L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 207510 |
| Manufacturer | LIFE-TECH INTL., INC. |
| Manufacturer Address | 4235 GREENBRIAR DR. STAFFORD TX 774773995 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-03-02 |