CODMAN #65-1031 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-19 for CODMAN #65-1031 * manufactured by Johnson & Johnson Medical Systems, Inc.

Event Text Entries

[21609020] During cranial surgery, adson periosteal elevator being used. Tip broke off and was retreived. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 389409
• MDR Report Key: 389409
• Date Received: 2002-04-19
• Date of Report: 2002-02-06
• Date of Event: 2002-01-25
• Date Facility Aware: 2002-02-04
• Report Date: 2002-02-06
• Date Added to Maude: 2002-04-24
• 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 #65-1031
• Generic Name: ADSON PERIOSTEAL ELEVATOR
• Product Code: GEG
• Date Received: 2002-04-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 378457
• Manufacturer: JOHNSON & JOHNSON MEDICAL SYSTEMS, INC
• Manufacturer Address: 425 HOES LANES PO BOX 6800 PISCATAWAY NJ 088556800 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-04-19