FDA.reportPublic FDA data

MAUDE MDR 6654374

MDR report key
6654374
Report number
3010611950-2017-00002
Event key
0
Event type
3
Date of event
2017-02-14
Date received
2017-06-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JANESSA BOONE
Address
3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US
Phone
608-608-6088
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ELITE PROBEELITE 3MHZ PROBENATUS NEUROLOGY, INCORPORATEDJAFX1L001N300N/AY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-2001. O

Event Narratives#

N

Patient 1

(B)(4). BASED ON RISK ASSESSMENT CONDUCTED MAY 25, 2017, IT WAS DETERMINED THAT THERE IS A RISK OF INJURY IF THE MALFUNCTION WERE TO RECUR. THERE HAVE BEEN NO REPORTED INJURIES. REFERENCE FIELD CORRECTIVE ACTION NUMBER: 3010611950/06/09/2017/001-R.

D

Patient 1

EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.