FDA Adverse Event
Injury
Summary report: N
COOK CHORIONIC VILLUS SAMPLING SET
MDR report key: 84496
·
Received April 11, 1997
Report
- Report Number
- 1825146-1997-90002
- Event Type
- Injury
- Date Received
- April 11, 1997
- Date of Event
- March 15, 1997
- Report Date
- April 11, 1997
- Manufacturer
- COOK OB/ GYN
- Product Code
- LLX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PREGNANCY OUTCOME FORM RETURNED BY THE HOSP STATES: "LIMB REDUCTION DEFECT INVOLVING 2 MIDDLE FINGERS OF ONE HAND. FILMS AND NOTES TO FOLLOW."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOK CHORIONIC VILLUS SAMPLING SET | SAMPLING DEVICE | LLX | COOK OB/ GYN | NA | 287554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DAY | Congenital Anomaly |