CODMAN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-25 for CODMAN * manufactured by Johnson & Johnson Professional, Inc..

Event Text Entries

[17762296] Tip from a tonsil clamp identified intraoperatively could not be seen at any point in the operative field, nor was this clearly visible on x-ray taken in the operating room.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015997
• MDR Report Key: 216386
• Date Received: 1999-03-25
• Date of Report: 1999-03-15
• Date of Event: 1998-07-29
• Date Added to Maude: 1999-03-31
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CODMAN
• Generic Name: TONSIL CLAMP
• Product Code: JYF
• Date Received: 1999-03-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 209892
• Manufacturer: JOHNSON & JOHNSON PROFESSIONAL, INC.
• Manufacturer Address: 325 PARAMOUNT DRIVE RAYNAM MA 027670350 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-03-25