FDA.reportPublic FDA data

MAUDE MDR 678284

MDR report key
678284
Report number
1018233-2006-00016
Event key
0
Event type
3
Date received
2006-02-17
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#

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
12006-02-1701. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A POST-IMPLANT FOLLOW-UP EXAMINATION, EXPOSED URETHRAL BULKING IMPLANT MATERIAL WAS OBSERVED IN THE PATIENT'S URETHRA. THE EXPOSED MATERIAL WAS EXTRACTED AND THE PATIENT WAS TREATED WITH MACROBID FOR POTENTIAL INFECTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.