FDA.reportPublic FDA data

MAUDE MDR 648947

MDR report key
648947
Report number
1018233-2005-00112
Event key
0
Event type
3
Date of event
2005-10-21
Date received
2005-11-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
VIVIAN STEPHENS
Address
8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD TEGRESS URETHRAL BULKING AGENTURETHRAL BULKING AGENTC.R. BARD, INC.LNMNA653001NAYRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-11-2201. R

Event Narratives#

D

Patient 1

WITHIN NINE DAYS OF A URETHRAL BULKING PROCEDURE BEING PERFORMED, THE DOCTOR NOTED THAT THE MATERIAL HAD ERODED THROUGH URETHRAL WALL INTO THE PATIENT'S VAGINA DISTAL TO BLADDER NECK. THE PATIENT PASSED THE MATERIAL VAGINALLY. NO FURTHER COMPLICATIONS WERE REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED.