FDA.reportPublic FDA data

MAUDE MDR 7169845

MDR report key
7169845
Report number
3010611950-2017-00048
Event key
0
Event type
3
Date of event
2017-11-21
Date received
2018-01-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1NICOLET VERSALAB LENICOLET VERSALABNATUS NEUROLOGY, INCORPORATEDJAFXVLB02XVLB02N/AN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-0501. O

Event Narratives#

N

Patient 1

(B)(4). PATIENT COMPLAINED OF LEG PAIN. THE VERSALAB WAS THEN USED TO PERFORM AN ABI EXAM. THE RANGES WERE DETERMINED TO BE IN NORMAL RANGE. THE CUSTOMER SENT THE PATIENT TO A SPECIALIST WHERE ADDITIONAL TESTS WERE CONDUCTED. IT IS UNCLEAR WHAT ADDITIONAL TESTS WERE CONDUCTED. BASED ON THOSE RESULTS, STENTS WERE PLACED IN THE PATIENT'S LEGS. THE VERSALAB IS 10 YEARS OLD, PAST RECOMMENDED PRODUCT LIFE. THE CUSTOMER BELIEVES THE VERSALAB IS FUNCTIONING AS INTENDED AND ARE NOT INTERESTED IN PURCHASING A NEW SYSTEM, NOR ARE THEY ABLE TO RETURN THEIR DEVICE BECAUSE THEY ONLY HAVE ONE SYSTEM AND IT IS NEEDED TO CONDUCT ABIS.

D

Patient 1

ABI READING NORMAL. PATIENT SENT TO SPECIALIST AND ARTERIAL DISEASE WAS DIAGNOSED.