GYNECARE THERMACHOICE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-04 for GYNECARE THERMACHOICE * manufactured by Ethicon, Inc.

MAUDE Entry Details

• Report Number: 3049327
• MDR Report Key: 3049327
• Date Received: 2013-04-04
• Date of Report: 2013-01-22
• Date of Event: 2013-01-10
• Report Date: 2013-01-22
• Date Reported to FDA: 2013-04-04
• Date Reported to Mfgr: 2013-04-10
• Date Added to Maude: 2013-04-10
• 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: GYNECARE THERMACHOICE
• Generic Name: CATHETER, BALLOON
• Product Code: MKN
• Date Received: 2013-04-04
• Model Number: *
• Catalog Number: *
• Lot Number: EHM613
• ID Number: *
• Operator: UNKNOWN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ETHICON, INC
• Manufacturer Address: RTE 22 PO BOX 151 SOMERVILLE NJ 08876 US 08876

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-04-04