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 |