FDA.reportPublic FDA data

MAUDE MDR 3266536

MDR report key
3266536
Report number
1718791-2013-00004
Event key
0
Event type
3
Date of event
2013-03-15
Date received
2013-04-18
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 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
1TEN20TEN20 CONDUCTIVE PASTED.O. WEAVER AND COMPANYGYB10-20-810-20-8126N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-04-1801. H; 2. R

Event Narratives#

D

Patient 1

PT HAD A SLEEP STUDY AT THE (B)(6) CENTER, BEGINNING AT 9PM ON (B)(6) 2013 AND ENDING AT 6AM ON (B)(6) 2013. PT SAID HIS SKIN WAS PREPPED WITH NUPREP SKIN PREP GEL, AND THAT THE TECHNICIANS SCRUBBED HIS SKIN VERY HARD, TO THE POINT OF CAUSING PAIN. PT STATED THAT HE WAS UNABLE TO FALL ASLEEP, SO HE WAS GIVEN A SLEEPING PILL, AND AFER A FEW HOURS, WAS STILL UNABLE TO FALL ASLEEP SO HE WAS GIVEN A SECOND SLEEPING PILL. PT STATED THAT HE WAS STILL VERY DROWSY WHEN HE DROVE HIMSELF HOME AFTER THE STUDY. WHEN HE ARRIVED AT HIS RESIDENCE, HIS VISION WAS QUITE BLURRY AND HIS SKIN WAS ITCHY AND STINGING. HE SAID HE EXPERIENCED BURNING, ITCHING, AND BLISTERING AROUND HIS SCALP, AND HIS EYES AND LIPS WERE SWOLLEN AND DRY. THE SKIN IRRITATION AND BLURRED VISION CONTINUED AND HE WAS NOT RELIEVED, HE DROVE HIMSELF TO THE ER AT (B)(6) HOSPITAL, AROUND 9PM ON (B)(6) 2013.

N

Patient 1

PT STATED THIS WAS HIS SECOND SLEEP STUDY AT THIS FACILITY, AND HE ENCOUNTERED NO PROBLEMS DURING THE FIRST STUDY. WE RECOMMENDED TO THE PT THAT HE SEE A DERMATOLOGIST. WE FOLLOWED UP WITH THE PT ON (B)(4) 2013. HE SAID THAT HE HAD SEEN A DERMATOLOGIST, AND THAT THE DERMATOLOGIST GAVE HIM PRESCRIPTIONS TO TREAT HIS REACTION. PT SAID THE SWELLING AROUND HIS EYES WAS DIMINISHED, BUT STILL THERE, AND THAT HIS SKIN PEELING. HE SAID HE IS SCHEDULED TO SEE THE DERMATOLOGIST AGAINST IN A WEEK OR SO. PT STATED THAT HE WAS SEEKING LEGAL ADVISE AND WOULD LIKE COMPENSATION FROM US. COMPLAINT HAS BEEN TURNED OVER TO INSURANCE COMPANY, WHO WILL BE CONDUCING ALL FURTHER FOLLOW UP WITH THE PT. PT LIKELY EXPERIENCED SOME SORT OF ALLERGIC REACTION, EITHER FROM OUR PRODUCT (NUPREP AND TEN20), OR FROM SOMETHING ELSE DURING THE SLEEP STUDY, SUCH AS THE SLEEPING PILLS. WE WILL SUBMIT A FOLLOW UP REPORT IF WE RECEIVE ADDITIONAL RELEVANT INFO PERTAINING TO THIS CASE. PT IS EXPECTED TO RECOVER. WE REQUESTED THE DEVICE BE RETURNED TO US BY THE USER FACILITY. HOWEVER, THEY DECLINED, STATING THAT THEY WERE REQUIRED TO KEEP THE DEVICE THERE SINCE THE PT ALSO FILED A COMPLAINT AT THE FACILITY.