MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-27 for ELECTRIC SHOCK TREATMENT MACHINE manufactured by Somatics Llc.
[176812315]
Through multiple bilateral and unilateral ect treatments over several months i had both temporary and permanent memory loss, loss of cognitive function, loss of facial recognition, loss of navigation ability, loss of ability to manage sensory input, overall loss of cognitive mental functioning. Subsequently developed essential body tremors in both hands. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092553 |
| MDR Report Key | 9637023 |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-24 |
| Date of Event | 2014-07-08 |
| Date Added to Maude | 2020-01-28 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTRIC SHOCK TREATMENT MACHINE |
| Generic Name | DEVICE, ELECTROCONVULSIVE THERAPY |
| Product Code | GXC |
| Date Received | 2020-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOMATICS LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2020-01-27 |