FDA.reportPublic FDA data

MAUDE MDR 3232350

MDR report key
3232350
Report number
1718791-2012-00015
Event key
0
Event type
3
Date of event
2012-09-14
Date received
2012-12-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. NICHOLAS LEE
Address
565-B NUCLA WAY, UNIT B AURORA CO 80011 US
Phone
303-303-3033
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TEN20 CONDUCTIVE PASTENEURODIAGNOSTIC CONDUCTIVE PASTED.O. WEAVER CO.GYB10-2010-20N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-12-1001. R

Event Narratives#

D

Patient 1

PT CALLED TO REQUEST A COPY OF MSDS FOR NUPREP AND TEN20. SHE STATED THAT SHE RECENTLY SUFFERED INJURIES DURING A RECENT LONG-TERM NEURODIAGNOSTIC EXAM AT THE EEG LAB AT (B)(6). DURING THE EXAM PREP ON (B)(6) 2012. PT NOTICED THE TECH SPRAY A SOLUTION CALLED NEUTRAL QUAT DISINFECTANT CLEANER CONCENTRATE ON THE ELECTRODES USED FOR HER EXAM. AFTERWARD, PT'S SKIN WAS PREPPED WITH NUPREP SKIN PREP GEL. DURING THIS TIME, PT TOLD THE TECH THAT SHE WAS SCRUBBING TOO HARD. THE EXAM PROCEEDED AND TEN20 CONDUCTIVE PASTE WAS USED INSIDE THE ELECTRODES, PRESSED ONTO THE SKIN, AND COLLODION WAS USED TO FURTHER ATTACH THE ELECTRODES. FINALLY, THE PT'S HEAD WAS WRAPPED TO HOLD EVERYTHING IN PLACE. PT SPENT SEVERAL DAYS IN PAIN, AND BURNING AN DITCHING WERE REPORTED BY THE PT TO THE EEG LAB. ELECTRODES WERE REMOVED ON (B)(6) 2012, AND THE PT NOTED THAT COLLODION REMOVER WAS USED TO ASSIST IN REMOVING THE ELECTRODES. PT STATED THAT AT THIS TIME THE BURNING INTENSIFIED. PT BELIEVES THAT A COMBINATION OF PRODUCTS AND MISUSE CAUSED HER INJURIES. PT STATED THAT SHE HAD BURNS, BLISTERS, AND RED SWOLLEN SKIN. PT WENT TO URGENT CARE ON (B)(6) 2012 AND WAS GIVEN A TOPICAL CREAM. ON (B)(6) 2012, PT VISITED PCP. PCP TOLD HER, SHE HAD ALLERGIC DERMATITIS AND REFERRED HER TO A DERMATOLOGIST. PT VISITED DERMATOLOGIST ON (B)(6) 2012. DERMATOLOGIST PRESCRIBED A DIFFERENT TOPICAL CREAM.

N

Patient 1

SPOKE WITH PT ON (B)(4) 2012. SHE STATED THAT HER SKIN HAS BEGUN TO HEAL AND HAD A FOLLOW UP APPT WITH DERMATOLOGIST ON (B)(6) 2012. DERMATOLOGIST DIAGNOSED PT WITH IRRITANT DERMATITIS. PT STILL EXPERIENCES DISCOMFORT AT ELECTRODE SITES, BUT BELIEVES IT IS GETTING BETTER. PT WILL FOLLOW UP WITH US IF HER CONDITION CHANGES.