FORCEPS, DALE GUARD, 7.5" LONG, NON STERILE 045720000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-07-16 for FORCEPS, DALE GUARD, 7.5" LONG, NON STERILE 045720000 manufactured by Cobe Cardiovascular, Inc..

MAUDE Entry Details

• Report Number: 1718850-2003-00016
• MDR Report Key: 472829
• Report Source: 05
• Date Received: 2003-07-16
• Date of Report: 2003-07-14
• Date of Event: 2003-04-25
• Date Added to Maude: 2003-07-23
• 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: JACK ELLISON, MGR
• Manufacturer Street: 14401 W 65TH WAY
• Manufacturer City: ARVADA CO 800043599
• Manufacturer Country: US
• Manufacturer Postal: 800043599
• Manufacturer Phone: 3034676306
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FORCEPS, DALE GUARD, 7.5" LONG, NON STERILE
• Generic Name: FORCEPS
• Product Code: KRI
• Date Received: 2003-07-16
• Model Number: NA
• Catalog Number: 045720000
• Lot Number: UNK
• ID Number: NA
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 461682
• Manufacturer: COBE CARDIOVASCULAR, INC.
• Manufacturer Address: 14401 WEST 65TH WAY ARVADA CO 800043599 US
• Baseline Brand Name: FORCEPS, DALE GUARD, 7.5" LONG, NON STERILE
• Baseline Generic Name: FORCEPS
• Baseline Model No: NA
• Baseline Catalog No: 045720000
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-07-16