FDA.reportPublic FDA data

MAUDE MDR 648935

MDR report key
648935
Report number
1018233-2005-00114
Event key
0
Event type
3
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.LNMNA653001NANRN

Patients#

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

Event Narratives#

D

Patient 1

WITHIN TWO MONTHS OF A URETHRAL BULKING IMPLANT, THE MATERIAL ERODED THROUGH THE MUCOSAL TISSUE. THE PHYSICIAN DECIDED NOT TO REMOVE THE ERODED TISSUE AND TO WAIT AND SEE IF THE MUCOSAL TISSUE HEALS OVER ON ITS OWN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.