FDA Adverse Event
Injury
Summary report: N
ECT MACHINE
MDR report key: 12814998
·
Received November 12, 2021
Report
- Report Number
- MW5105336
- Event Type
- Injury
- Date Received
- November 12, 2021
- Date of Event
- January 1, 2008
- Report Date
- November 10, 2021
- Manufacturer
- UNK
- Product Code
- GXC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
I RECEIVED IN AND OUT PATIENT ECT TREATMENT (UP TO 25 TIMES) WHICH RESULTED IN PERMANENT BRAIN DAMAGE. I HAVE BEEN UNABLE TO WORK THE PAST 12 YEARS, HAD TO RELEARN HOW TO READ AND WRITE AND AM ON DISABILITY AT A YOUNG AGE. ECT DESTROYED MY CAREER, FAMILY AND LIFE. WHICHEVER ONES USED BY IHC IN SL. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1699891 | ECT MACHINE | DEVICE, ELECTROCONVULSIVE THERAPY | GXC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Disability| R| H |