FDA.reportPublic FDA data

MAUDE MDR 8627960

MDR report key
8627960
Report number
1718791-2019-00002
Event key
0
Event type
3
Date of event
2019-03-25
Date received
2019-05-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
501
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

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

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TEN20 CONDUCTIVE PASTEADHESIVE CONDUCTIVE ELECTRODE PASTED.O. WEAVER AND COMPANYGYB10-20N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-2101. O

Event Narratives#

N

Patient 1

NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY COMPLAINANT. PATIENT AND COMPLAINANT ARE MORE CONCERNED WITH WHO IS GOING TO PAY FOR THE PATIENT'S VISIT TO THE DERMATOLOGIST. NO INFORMATION RECEIVED SUGGESTS THAT PERMANENT DAMAGE WILL RESULT FROM THE HAIR LOSS. HOWEVER, IF WE RECEIVE ADDITIONAL INFORMATION, WE WILL SUBMIT A FOLLOW-UP REPORT. BASED ON RECEIVED INFORMATION, IT IS LIKELY THAT THE PATIENT'S HAIR DYE AND HAIR EXTENSIONS CONTRIBUTED TO THE HAIR LOSS. TEN20 IS WATER SOLUBLE AND SHOULD EASILY RINSE OUT FROM THE HAIR WITH WARM WATER.

D

Patient 1

RECEIVED PHONE CALL FROM MANAGER OF A SLEEP LAB REGARDING A PATIENT THAT EXPERIENCED HAIR LOSS AFTER A SLEEP STUDY. PATIENT CLAIMS THAT AFTER THE STUDY THERE WAS STILL SOME ELECTRODE PASTE STUCK IN HER HAIR. UPON TRYING TO REMOVE IT, SHE CLAIMS THAT THE HAIR AT THE ELECTRODE SITES FELL OUT. WE RECOMMENDED THAT THE PATIENT SEE HER DOCTOR OR A DERMATOLOGIST.