FDA.reportPublic FDA data

MAUDE MDR 378571

MDR report key
378571
Report number
1018233-2002-00002
Event key
0
Event type
3
Date of event
2002-01-25
Date received
2002-02-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
112
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
VIVIAN STEPHENS, MANAGER
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 WOVEN PHILLIPS FOLLOWERURETHRAL CATHETERC.R. BARD, INC.KOENA021516UNKNYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-02-2201. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A URETHRAL DILATION PROCEDURE BEING PERFORMED IN THE PATIENT'S HOME, THE THREADED TIP OF A REUSABLE FOLLOWER INCLUDING THE ATTACHED FILIFORM BROKE OFF AND REMAINED INSIDE THE PATIENT. CONSULT WITH PHYSICIAN, PROVIDED INSTRUCTIONS TO GIVE PATIENT IM ANTIBIOTICS AND ANTI-INFLAMMATORIES AND WAIT TO SEE IF PT PASSED METAL TIP. NO ACUTE URINARY BLEEDING OR OBSTRUCTION OCCURRED AND PATIENT WAS ABLE TO VOID OUT THE PIECE WITHIN A FEW DAYS. PRODUCT DATE CODE INDICATED PRODUCT WAS MANUFACTURED IN JANUARY OF 1991. PRODUCT WAS STERILIZED BETWEEN USES WITH CYDEX AND WATER.