CODMAN DISPOSABLE PERFORATOR 26-1221

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-31 for CODMAN DISPOSABLE PERFORATOR 26-1221 manufactured by Codman Johnson & Johnson.

Event Text Entries

[429746] Craniotomy burr holes being made as part of procedure. During second burr hole drilling, the clutch mechanism failed and the perforator penetrated the dora and resulting in contusion of underlying brain.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 644115
• MDR Report Key: 644115
• Date Received: 2005-10-31
• Date of Report: 2005-10-26
• Date of Event: 2005-07-29
• Date Facility Aware: 2005-08-03
• Report Date: 2005-10-26
• Date Reported to FDA: 2005-10-31
• Date Added to Maude: 2005-11-03
• 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: 3
• Reporter Occupation: RISK MANAGER
• 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 DISPOSABLE PERFORATOR
• Generic Name: DISPOSABLE PERFORATOR
• Product Code: KAT
• Date Received: 2005-10-31
• Model Number: 26-1221
• Catalog Number: 26-1221
• Lot Number: DX880
• ID Number: NA
• Device Expiration Date: 2010-04-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 633614
• Manufacturer: CODMAN JOHNSON & JOHNSON
• Manufacturer Address: 325 PARAMOUNT DRIVE * *
• Baseline Brand Name: CODMAN DISPOSABLE PERFORATOR
• Baseline Generic Name: COMPOUOND DRILL
• Baseline Model No: NA
• Baseline Catalog No: 26-1221
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2005-10-31