MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-03-20 for ECTDEVICE manufactured by Mecta Corporation.
[139367202]
No further information available. Attempted to contact patient several times by several methods with no success.
Patient Sequence No: 1, Text Type: N, H10
[139367203]
Patient received (their statement) involuntary ect treatments (2 over a period of 3 days) in 2001. Claims "the minute i got home ect did not work and petrified of my blank mind. " was unable to work and began receiveing social security disability insurance. Other problems followed. Basically, life was ruined. See medwatch report mw5082259 for more details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3020533-2019-00002 |
| MDR Report Key | 8437620 |
| Report Source | OTHER |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2001-01-01 |
| Date Mfgr Received | 2019-01-04 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS. ROBIN NICOL |
| Manufacturer Street | 19799 SW 95TH AVENUE SUITE B |
| Manufacturer City | TUALATIN OR 97062 |
| Manufacturer Country | US |
| Manufacturer Postal | 97062 |
| Manufacturer Phone | 5036126780 |
| Manufacturer G1 | MECTA CORPORATION |
| Manufacturer Street | 19799 SW 95TH AVENUE SUITE B |
| Manufacturer City | TUALATIN OR 97062 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ECTDEVICE |
| Product Code | GXC |
| Date Received | 2019-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MECTA CORPORATION |
| Manufacturer Address | 19799 SW 95TH AVE. SUITE B TUALATIN OR 97062 US 97062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-20 |