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