FDA.reportPublic FDA data

MAUDE MDR 645730

MDR report key
645730
Report number
1018233-2005-00095
Event key
0
Event type
3
Date of event
2005-10-04
Date received
2005-11-14
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.LNMNA653001NANRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-11-1401. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT WHEN THE DR WAS PERFORMING THE SECOND URETHRAL BULKING PROCEDURE ON THE SAME PT, HE NOTED EXPOSURE MATERIAL THROUGH THE URETHRAL WALL FROM THE PREVIOUS TREATMENT. NO STEPS WERE TAKEN TO CORRECT SITUATION AS THE DR FEELS THE CONDITION WILL SELF-CORRECT. THE DR CONTINUED THE RE-TREATMENT AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.