CODMAN DISPOSABLE PERFORATOR 26-1221

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-08-20 for CODMAN DISPOSABLE PERFORATOR 26-1221 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[18108230] It was reported that the disposable perforator failed to disengage during a craniotomy and the drill cut into the patient's dura.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1223648-2003-00187
• MDR Report Key: 479200
• Report Source: 05,06
• Date Received: 2003-08-20
• Date of Report: 2003-07-22
• Date Mfgr Received: 2003-07-22
• Date Added to Maude: 2003-08-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Manufacturer Contact: MATTHEW KING
• Manufacturer Street: 325 PARAMOUNT DRIVE
• Manufacturer City: PAYNHAM MA 02767
• Manufacturer Country: US
• Manufacturer Postal: 02767
• Manufacturer Phone: 5088283106
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Generic Name: COMPOUOND DRILL
• Product Code: KAT
• Date Received: 2003-08-20
• Model Number: NA
• Catalog Number: 26-1221
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 468025
• Manufacturer: CODMAN & SHURTLEFF, INC.
• Manufacturer Address: NEW BEDFORD INDUSTRIAL PARK NEW BEDFORD MA 02745 US
• 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. Other	2003-08-20