FDA Adverse Event
Injury
Summary report: N
ECT MACHINE
MDR report key: 14162316
·
Received April 19, 2022
Report
- Report Number
- MW5109199
- Event Type
- Injury
- Date Received
- April 19, 2022
- Date of Event
- February 16, 2022
- Report Date
- April 17, 2022
- Manufacturer
- UNK
- Product Code
- QGH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
I WAS COERCED INTO RECEIVING ECT TREATMENT WHILE HOSPITALIZED DURING A MENTAL HEALTH CRISIS. ECT HAS LEFT ME WITH SIGNIFICANT MEMORY AND COGNITIVE DEFICITS, AND INCREASED DIFFICULTY IN MAINTAINING ATTENTIVENESS AND FORMING NEW MEMORIES. I WAS UNABLE TO RETURN TO MY JOB AFTER HOSPITALIZATION AND ECT TREATMENTS. I DISCONTINUED ECT BEFORE THE END OF MY PRESCRIBED TREATMENT COURSE BECAUSE OF THE SEVERITY OF THE MEMORY AND COGNITIVE PROBLEMS. WHOEVER SOLD TO (B)(6). FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2626944 | ECT MACHINE | ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B | QGH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Disability | CANNABIS |