FDA.reportPublic FDA data

MAUDE MDR 268441

MDR report key
268441
Report number
1018233-2000-00005
Event key
0
Event type
3
Date of event
1996-01-16
Date received
2000-03-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
0

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
1EXACT BRAND NAME UNKPENROSE DRAINC.R. BARD, INC.GCYNAUNKUNKNNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-03-0901. O

Event Narratives#

D

Patient 1

PLAINTIFF'S ATTORNEY ALLEGED THAT PLAINTIFF'S CONTACT WITH A PENROSE DRAIN RESULTED IN LATEX ALLERGIC REACTION. THE "RE" WAS NO COMPLAINT FILED BY THE PLAINTIFF OR THE HEALTH CARE FACILITY WHEN THE ALLEGED EVENT OCCURRED. THIS INFO WAS REPORTED TO LAW DEPT. AND IS BEING HANDLED BY THEM.