CODMAN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-23 for CODMAN * manufactured by *.

Event Text Entries

[20887287] 14mm perforator was being used to make the initial burr hole, when the burr hole was complete and the bone was complete and the bone had been drilled through the perforator automatically stops and locks up to prevent going into dura or brain. This one would not stop or lockup!
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 252047
• MDR Report Key: 252047
• Date Received: 1999-11-23
• Date of Report: 1999-10-21
• Date of Event: 1999-10-21
• Report Date: 1999-10-21
• Date Added to Maude: 1999-12-03
• 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: PERFORATOR 14MM
• Product Code: KAT
• Date Received: 1999-11-23
• Model Number: *
• Catalog Number: *
• Lot Number: ER869
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 244104
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-11-23