FDA.reportPublic FDA data

MAUDE MDR 285599

MDR report key
285599
Report number
1018233-2000-00022
Event key
0
Event type
3
Date of event
1997-02-15
Date received
2000-07-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
VIVIAN STEPHENS
Address
8195 INDUST. 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
1LATEX GLOVESLATEX GLOVESUNKLYYNAUNKUNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-07-1101. R

Event Narratives#

D

Patient 1

PT BEING TREATED IN EMERGENCY ROOM FOR NONRELATED CONDITION WAS CATHETERIZED WITH A BARD FOLEY CATHETER (NATURAL RUBBER LATEX) WHEN FACE BECAME FLUSHED AND HIVES AND ANGIOEDEMA DEVELOPED IMMEDIATELY. TREATMENT INCLUDED STANDARD TREATMENT FOR ANAPHYLAXIS. SUSPECT MEDICAL DEVICE WAS STATED AS "LATEX GLOVES" ON VOLUNTARY REPORT.