MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-19 for MICROVAS * manufactured by Microvas.
[15027725]
Was interested in getting treatments from the firm's device because has neuropathy. Firm sent material claiming to cure 84 diseases and that 4-5 problems can be treated at once. Thought these claims were misleading.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003923 |
| MDR Report Key | 597105 |
| Date Received | 2005-04-19 |
| Date of Report | 2005-03-15 |
| Date Added to Maude | 2005-05-02 |
| 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 | 3 |
| 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 | MICROVAS |
| Generic Name | ELECTRICAL MUSCLE STIMULATOR |
| Product Code | GZC |
| Date Received | 2005-04-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 586934 |
| Manufacturer | MICROVAS |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-19 |