MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-21 for TRIVARION DELIVERY KIT * manufactured by Activatek.
[2218976]
Iontophoresis-medication delivered by an electrical current. No tinging or discomfort during treatment, however, a brownish colored blister was noticed when therapist removed medication patch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2318194 |
| MDR Report Key | 2318194 |
| Date Received | 2011-10-21 |
| Date of Report | 2011-10-21 |
| Date of Event | 2011-08-26 |
| Report Date | 2011-10-21 |
| Date Reported to FDA | 2011-10-21 |
| Date Added to Maude | 2011-11-01 |
| 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 | 3 |
| 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 | TRIVARION DELIVERY KIT |
| Generic Name | TRIVARION DELIVERY KIT |
| Product Code | EGJ |
| Date Received | 2011-10-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 104947 |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACTIVATEK |
| Manufacturer Address | 2734 SOUTH 3600 WEST UNIT F WEST VALLEY UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-21 |