FDA.reportPublic FDA data

MAUDE MDR 4181171

MDR report key
4181171
Report number
1049092-2014-00517
Event key
0
Event type
3
Date of event
2014-09-17
Date received
2014-10-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MATTHEW WALENCIAK, ASSOC. DIR.
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-INTRA ABDOMINAL PRESSURE MONITORDEVICE, CYSTOMETRIC, HYDRAULICCONVATEC, INC.FENABV321ABV321130217R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-10-140

Event Narratives#

D

Patient 1

IT IS REPORTED THAT AFTER NINE (9) DAYS OF PLACEMENT OF THE DEVICE ON A PT FROM THE ICU, INSUFFLATION WITH 20CC OF SALINE SOLUTION WAS PERFORMED. ALTHOUGH THE MEASURE OF THE INTRA-ABDOMINAL PRESSURE WAS TAKEN CORRECTLY, THE AUTOMATIC VALVE DID NOT COLLAPSE.

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. THE PHYSICIAN WAITED FOR SOME MINUTES AND DECIDED TO REMOVE THE DEVICE SINCE THE PT WAS NOT IN A CRITICAL STATE. THE DEVICE WAS DISCARDED AND UPON REVISION THE DAY AFTER, THE VALVE WAS STILL DISTENDED. AN INVESTIGATION WAS PERFORMED BY THE THIRD PARTY MANUFACTURING SITE THAT INCLUDED A HISTORICAL REVIEW OF THE BATCH RECORDS FOR THE PAST SIX MONTHS TO DATE OF MANUFACTURE OF THE COMPLAINT LOT. ALL THE TESTINGS MET SPECIFICATION AND PERFORMANCE REQUIREMENTS. NO ROOT CAUSE WAS DETERMINED SINCE THE DEVICE HAD BEEN DISCARDED. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.