FDA Adverse Event
Injury
Summary report: N
TROPHOCAN CVS CATHETER
MDR report key: 57121
·
Received December 20, 1996
Report
- Report Number
- 1217052-1996-00094
- Event Type
- Injury
- Date Received
- December 20, 1996
- Date of Event
- July 20, 1996
- Report Date
- September 4, 1996
- Manufacturer
- SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
- Product Code
- LLX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
THE CVS PROCEDURE WAS PERFORMED AND INTRAUTERINE FETAL DEMISE OF TWIN FETUSES OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROPHOCAN CVS CATHETER | CATHETER SAMPLING CHORIONIC VILLUS | LLX | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention | A SYRINGE| TO |