CODMAN * 63-4031

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-15 for CODMAN * 63-4031 manufactured by Codman.

Event Text Entries

[19076412] Vein stripper got caught in valve in vein. Surgeon had to re-prep and drape and extend incision higher up leg.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 361331
• MDR Report Key: 361331
• Date Received: 2001-11-15
• Date of Report: 2001-11-14
• Date of Event: 2001-11-14
• Date Facility Aware: 2001-11-14
• Report Date: 2001-11-14
• Date Added to Maude: 2001-11-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CODMAN
• Generic Name: DISPOSABLE VEIN STRIPPER
• Product Code: GAJ
• Date Received: 2001-11-15
• Model Number: *
• Catalog Number: 63-4031
• Lot Number: ET449
• ID Number: *
• Device Expiration Date: 2006-05-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 350488
• Manufacturer: CODMAN
• Manufacturer Address: * RAYNHAM MA 027670350 US
• Baseline Brand Name: CODMAN DISPOSABLE VEIN STRIPPER
• Baseline Generic Name: STRIPPER, VEIN, DISPOSABLE
• Baseline Model No: NA
• Baseline Catalog No: 63-4031
• Baseline ID: NA
• Baseline Device Family: CODMAN DISPOSABLE VEIN STRIPPER
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 60
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-11-15