UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-14 for UNK * manufactured by Unk.

Event Text Entries

[361844] Cobb elevator broke off in patient- rusted at handle junction. Rust particles on sterile field, in wound. Wound cleaned out by physician. Wound irrigated with bacitracin irrigation. All sterile personnel changed gloves.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 539847
• MDR Report Key: 539847
• Date Received: 2004-07-14
• Date of Report: 2004-07-14
• Date of Event: 2004-05-09
• Report Date: 2004-07-14
• Date Reported to FDA: 2004-07-14
• Date Added to Maude: 2004-08-20
• 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
• 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: UNK
• Generic Name: COBB ELEVATOR
• Product Code: GEG
• Date Received: 2004-07-14
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 529151
• Manufacturer: UNK
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-07-14