MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-30 for PROELECT DT * manufactured by Matrix Electromedical, Inc..
[17025595]
"this device was used on me with the doctor saying it's safe, no side effects, 5th treatment doctor got upset and fast talked me into another treatment but this time, he changed position of the electrodes, placing them on my wire in my neck where it is fused together and on my spine where i had no pain. And almost behind my heart. " rptr had swelling in neck after this, and couldn't talk for 3 weeks. "i'm very sick i can't write all my symptoms and treatment down on one paper for this very dangerous device. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012035 |
| MDR Report Key | 117745 |
| Date Received | 1997-08-30 |
| Date of Report | 1997-08-26 |
| Date of Event | 1997-03-13 |
| Date Added to Maude | 1997-09-09 |
| 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 | PATIENT |
| 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 | PROELECT DT |
| Generic Name | * |
| Product Code | LIH |
| Date Received | 1997-08-30 |
| Model Number | PROELECT DT |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 115480 |
| Manufacturer | MATRIX ELECTROMEDICAL, INC. |
| Manufacturer Address | 4208 ARCATA WAY LAS VEGAS NV 89030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1997-08-30 |