FDA Adverse Event
Other
Summary report: N
ELECTROSCOPE AEM CORD
MDR report key: 290085
·
Received August 9, 2000
Report
- Report Number
- 1722040-2000-00005
- Event Type
- Other
- Date Received
- August 9, 2000
- Date of Event
- July 28, 2000
- Report Date
- August 8, 2000
- Manufacturer
- ENCISION INC.
- Product Code
- GEI
- Removal / Correction Number
- 1722040-12/17/1999-R
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER STATED, "CORD SPARKED AND EM2 DIDN'T ALARM". NO PT OR USER INJURY REPORTED. DETAILS OF EVENT ARE REPORTED BY CUSTOMER IN MEDWATCH REPORT 000370114-2000-006.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECTROSCOPE AEM CORD | ACTIVE ELECTRODE MONITORING SYSTEM COMPONENT | GEI | ENCISION INC. | ES4007 | BJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |