FDA.reportPublic FDA data

MAUDE MDR 8487914

MDR report key
8487914
Report number
9610691-2019-00005
Event key
0
Event type
3
Date of event
2019-01-16
Date received
2019-04-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SANJAY PARIKH
Address
6230 OLD DOBBIN LANE SUITE 250 COLUMBIA MD 21045 US
Phone
410-410-4107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMBU NEUROLINE CUP ELECTRODESAMBU EEG LEADSAMBU A/SGXYUNKNOWNN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-0501. O

Event Narratives#

N

Patient 1

THERE WERE NO CATALOG NUMBER, LOT NUMBER OR COMPLAINT SAMPLE AVAILABLE FOR FURTHER INVESTIGATIONS. THE COMPLAINT WAS RECEIVED THROUGH A FDA MAUDE REPORT, WHICH ONLY IDENTIFY THAT AN AMBU EEG ELECTRODES WERE INVOLVED IN THE DESCRIBED EVENT, WITHOUT ANY SPECIFICATIONS ON THE PRODUCT. NEITHER DID THE MAUDE REPORT INCLUDE NAME OR CONTACT INFORMATION OF THE INITIAL REPORTER, SO NO FOLLOW-UP QUESTIONS COULD BE ASKED. WE WERE THEREFORE UNABLE TO INVESTIGATE THE FAILURE DUE TO LIMITED AND INCOMPLETE INFORMATION PROVIDED. HOWEVER, AMBU CUP EEG ELECTRODES ARE INTENDED ONLY FOR RECORDING BIOPOTENTIAL SIGNALS, AND DO NOT ACT AS A STIMULATOR, MEANING THAT THE ELECTRODES ARE PASSIVE AND CAN NOT GENERATE ANY CURRENT AND THEREBY NOT CAUSE ELECTRICAL BURNS WHEN USED ACCORDING TO IFU.

D

Patient 1

PATIENT WAW WEARING THE CUP-ELECTRODES OVER A PROXIMAL PERIOD OF 24H, AND EXPERIENCED RED BURNS, WHEN REMOVING THE ELECTRODES.