FDA.reportPublic FDA data

MAUDE MDR 6002576

MDR report key
6002576
Report number
1049092-2016-00418
Event key
0
Event type
3
Date of event
2016-09-12
Date received
2016-10-06
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
MRS. JEANETTE JOHNSON
Address
7900 TRIAD CENTER DRIVE SUITE 400 GREENSBORO NC 27409 US
Phone
336-336-3365
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ABVISER??AUTOVALVE??IAP MONITORING DEVICEDEVICE, CYSTOMETRIC, HYDRAULICCONVATEC INC.FENABV301140600Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-060

Event Narratives#

N

Patient 1

EXPIRATION DATE (05/2017). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO PATIENT HARM WAS REPORTED. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NONE PROVIDED TO DATE. THE DEVICE HAS BEEN RETURNED FOR EVALUATION AND WAS FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON OCTOBER 06, 2016. (B)(4).

D

Patient 1

THE REPORTER STATED, "ON THIRD DAY OF USAGE (APPROXIMATELY 70 HOURS), THE NURSE DISCOVERED THAT THERE WAS NO URINE OUTPUT FROM THE PATIENT. AFTER CHECKING ALL THE POSSIBLE REASONS, THE AUTO-VALVE WAS FOUND NOT DEFLATED." REPORTER STATED THAT THE DEVICE WAS REPLACED. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.