FDA.reportPublic FDA data

MAUDE MDR 4579988

MDR report key
4579988
Report number
1049092-2015-00129
Event key
0
Event type
3
Date of event
2015-01-30
Date received
2015-03-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MATTHEW WALENCIAK, INTERIM ASSOC
Address
211 AMERICAN AVE. GREENSBORO NC 27409 US
Phone
908-908-9083
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ABVISER AUTOVALVE VALVE IAP MONITORING DEVICECONVATEC INC.FENABV301R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-040

Event Narratives#

D

Patient 1

A NURSE REPORTED THAT THE DEVICE WAS PLACED IN THE PT ON (B)(6) 2015 AND AFTER MANY TRIES, IT WAS NOTED THAT THE DEVICE WAS NOT WORKING CORRECTLY AS IT PRESENTED BOTH NEGATIVE VALUES AND HIGH VALUES IN THE SAME TIME. THE NURSE FURTHER REPORTED THAT THE DEVICE WAS REMOVED ON THE SAME DAY.

N

Patient 1

BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.