VERSEO EPEN 100871-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-21 for VERSEO EPEN 100871-01 manufactured by Sharper Image.

Event Text Entries

[18973185] After four weekly uses, the finger i used to depress the activation button began to lose sensation. The tip of my finger became painful to the touch, and it was difficult to write with a pen. I was suspicious that this device was the culprit. I took a multimeter and measured the voltage at the activation button against ground. It measured 12 volts when operating! This voltage was even higher than the voltage at the application tip! Obviously there is either a manufacturing defect or a serious design flaw. I am an electrical engineer by degree, and can tell you that prolonged exposure of 12 volts to the skin is harmful. This item should be recalled. (b)(4). Manufacturer website url: sharperimage. Com. Purchase date: (b)(6) 2011. The product was not damaged before the incident. The product was not modified before the incident. I have reported this to sharper imager via "rate this product. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5024036
MDR Report Key	2434291
Date Received	2012-01-21
Date of Report	2012-01-21
Date of Event	2011-12-13
Date Added to Maude	2012-02-01
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	0
Reporter Occupation	PATIENT
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	0
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	VERSEO EPEN
Generic Name	ELECTROLYSIS PEN
Product Code	KCX
Date Received	2012-01-21
Model Number	100871-01
Device Availability	Y
Device Sequence No	1
Device Event Key	0
Manufacturer	SHARPER IMAGE

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-01-21