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