FDA Adverse Event
Injury
Summary report: N
ECTDEVICE
MDR report key: 8437620
·
Received March 20, 2019
Report
- Report Number
- 3020533-2019-00002
- Event Type
- Injury
- Date Received
- March 20, 2019
- Date of Event
- January 1, 2001
- Report Date
- March 20, 2019
- Manufacturer
- MECTA CORPORATION
- Product Code
- GXC
- PMA / PMN Number
- K965070
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION AVAILABLE. ATTEMPTED TO CONTACT PATIENT SEVERAL TIMES BY SEVERAL METHODS WITH NO SUCCESS.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230702 | ECTDEVICE | GXC | MECTA CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |