MEM-4104K MEM4104-K *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-29 for MEM-4104K MEM4104-K * manufactured by Nihon Kohden.

Event Text Entries

[229086] Electrical stimulation was not working. Electrodes contacts created superficial skin burns on the pt and later on the tech when they tried to duplicate the abr procedure on themselves. The pt did not complaint about the burn but claimed of slight stinging on their right ear during auditory testing. The electrodes were not mfg by nkc. No info on the electrodes condition is available. The product has been obsolete since 12/1992.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2080783-2002-00001
• MDR Report Key: 391518
• Date Received: 2002-04-29
• Date of Report: 2002-04-29
• Date of Event: 2002-03-06
• Date Facility Aware: 2002-04-02
• Report Date: 2002-04-26
• Date Reported to FDA: 2002-04-26
• Date Reported to Mfgr: 2002-04-02
• Date Added to Maude: 2002-05-06
• Event Key: 0
• Report Source Code: Distributor 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: MEM-4104K
• Generic Name: EP/EMG
• Product Code: GWL
• Date Received: 2002-04-29
• Model Number: MEM4104-K
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 12 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 380566
• Manufacturer: NIHON KOHDEN
• Manufacturer Address: 31-4 NISHIOCHIAI 1-CHOME SHINJUKU-KU TOKYO JA 161

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-04-29