COOK CHORIONIC VILLUS SAMPLING SET J-CVS-572700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-06-12 for COOK CHORIONIC VILLUS SAMPLING SET J-CVS-572700 manufactured by Cook Ob/gyn.

Event Text Entries

[97142] Pregnancy outcome card received from hosp states that the baby was born with a "cleft/lip palate. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1825146-1998-90003
• MDR Report Key: 172885
• Report Source: 05
• Date Received: 1998-06-12
• Date of Report: 1998-06-10
• Date of Event: 1997-08-11
• Date Facility Aware: 1998-05-28
• Report Date: 1998-06-10
• Date Mfgr Received: 1998-05-28
• Date Added to Maude: 1998-06-19
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Remedial Action: PM
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COOK CHORIONIC VILLUS SAMPLING SET
• Generic Name: SAMPLING DEVICE
• Product Code: LLX
• Date Received: 1998-06-12
• Model Number: NA
• Catalog Number: J-CVS-572700
• Lot Number: UN
• ID Number: UN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 168107
• Manufacturer: COOK OB/GYN
• Manufacturer Address: 1100 WEST MORGAN ST SPENCER IN 47460 US
• Baseline Brand Name: COOK CHORIONIC VILLUS SAMPLING SET
• Baseline Generic Name: SAMPLING DEVICE
• Baseline Model No: NA
• Baseline Catalog No: J-CVS-572700
• Baseline ID: NA
• Baseline Device Family: UNCLASSIFIED
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 60
• Baseline PMA Flag: Y
• Premarket Approval: P9000
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Congenital Not Applicablenomaly	1998-06-12