MAUDE MDR 2434291

MDR report key
2434291
Report number
MW5024036
Event key
0
Event type
3
Date of event
2011-12-13
Date received
2012-01-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VERSEO EPENELECTROLYSIS PENSHARPER IMAGEKCX100871-01 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-01-210

Event Narratives#

D

Patient 1

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."