FDA Adverse Event
Other
Summary report: N
COOK CHORIONIC VILLUS SAMPLING SET
MDR report key: 172885
·
Received June 12, 1998
Report
- Report Number
- 1825146-1998-90003
- Event Type
- Other
- Date Received
- June 12, 1998
- Date of Event
- August 11, 1997
- Report Date
- June 10, 1998
- Manufacturer
- COOK OB/GYN
- Product Code
- LLX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PREGNANCY OUTCOME CARD RECEIVED FROM HOSP STATES THAT THE BABY WAS BORN WITH A "CLEFT/LIP PALATE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOK CHORIONIC VILLUS SAMPLING SET | SAMPLING DEVICE | LLX | COOK OB/GYN | NA | UN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Congenital Anomaly |