FDA.reportPublic FDA data

MAUDE MDR 3841102

MDR report key
3841102
Report number
1018233-2014-00100
Event key
0
Event type
3
Date of event
2014-04-17
Date received
2014-05-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHRISTY LEWIS
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
1BLADDER CARE TRAY KITBARD SDN. BHD.EZCNA882286UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-05-1301. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING AN EDUCATIONAL CLASS A NURSE PICKED UP A LATEX CATHETER. THE NURSE HAD A LATEX ALLERGY AND HAD AN ALLERGIC REACTION. THE NURSE HAD TAKEN BENADRYL, AS WELL AS GO TO THE ER. IT IS UNKNOWN IF A SECONDARY INTERVENTION WAS PERFORMED.

N

Patient 1

INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.