FDA.reportPublic FDA data

MAUDE MDR 679049

MDR report key
679049
Report number
1018233-2006-00019
Event key
0
Event type
3
Date received
2006-02-22
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#

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
12006-02-2201. R

Event Narratives#

D

Patient 1

DURING A POST-IMPLANT FOLLOW-UP EXAMINATION, EXPOSED URETHRAL BULKING IMPLANT MATERIAL WAS OBSERVED IN THE PATIENT'S BLADDER. THE EXPOSED MATERIAL WAS REMOVED VIA CYSTOSCOPY WITH GRASPING FORCEPS. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.