CELL PHONE SCH-A670 UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-31 for CELL PHONE SCH-A670 UNK manufactured by Samsung America, Inc.

Event Text Entries

[21960112] A customer was on the cell phone for about 10 minutes a couple of days ago, his side of the face got hot and numb. Contact once again was on his house cordless phone. Yesterday for about 10 to 15 minutes. The side of face was red, hot and numb. Contact has headache, nauseated and not feeling well since yesterday.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1039880
• MDR Report Key: 751428
• Date Received: 2006-07-31
• Date of Report: 2006-07-31
• Date of Event: 2006-07-30
• Date Added to Maude: 2006-08-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• 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 Sequence Number: 1

• Brand Name: CELL PHONE
• Generic Name: *
• Product Code: NCO
• Date Received: 2006-07-31
• Model Number: SCH-A670
• Catalog Number: UNK
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 739241
• Manufacturer: SAMSUNG AMERICA, INC
• Manufacturer Address: 105 CHALLENGED RD RIDGEFIELD PARK NJ 07660 US

Device Sequence Number: 2

• Brand Name: HOME CORDLESS PHONE
• Generic Name: *
• Date Received: 2006-07-31
• Model Number: IA5854
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 739511
• Manufacturer: VTECH COMMUNICATIONS, INC.
• Manufacturer Address: 9590 SW GEMINI DR. SUITE 120 BEAVERTON OR 97008 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2006-07-31