FDA.reportPublic FDA data

MAUDE MDR 5834734

MDR report key
5834734
Report number
2435501-2016-00001
Event key
0
Event type
3
Date of event
2016-05-19
Date received
2016-07-29
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
MR. KALMAN GROF-TISZA
Address
115 TREE ST FLOWOOD MS 39232 US
Phone
855-855-8558
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIFETEC ELITE V1.0LIFETEC ELITEIT SYNERGISTICS, LLCMMHNANANAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-290

Event Narratives#

N

Patient 1

(B)(4)

D

Patient 1

ON 6/02/2016 IT SYNERGISTICS, (HEREIN AFTER ITSY) WAS MADE AWARE OF AN ISSUE FROM CUSTOMER (B)(6), WHERE THE LIFETEC ELITE V1.0 510(K) BK060032 DID NOT APPLY A PRODUCT LEVEL LAB HOLD ON A UNIT OF BLOOD ON (B)(6) 2016 THAT HAD AN ASSOCIATED POSITIVE TEST RESULT, WHICH ALLOWED THE SUSPECT PRODUCT TO BE SOLD. IT HAS BEEN DETERMINED THAT THE INITIAL POSITIVE LABORATORY TEST WAS CONFIRMED NEGATIVE.