FDA.reportPublic FDA data

MAUDE MDR 576772

MDR report key
576772
Report number
1423507-2005-00024
Event key
0
Event type
3
Date received
2005-03-01
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
MICHELE DONATICH
Address
1430 WAUKEGAN RD BLDG KB MCGAW PARK IL 60085 US
Phone
847-847-8475
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GLV EXAM PF ESTEEM NEU-THERA NITRILE MEDNITRILE EXAM GLOVECARDINAL HEALTHLZC*N88RX03TUNKK032444NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-03-0101. O

Event Narratives#

D

Patient 1

SIX INDIVIDUALS FROM HOUSEKEEPING DEVELOPED REDNESS AND ITCHY BUMPS ON THEIR HANDS AFTER WEARING THE GLOVE. THE INCIDENTS STARTED IN JAN. 2005. THEY WENT TO EMPLOYEE HEALTH AND THE PHYSICIAN THERE PRESCRIBED SYNALAR CREAM. ALSO THEY WERE INSTRUCTED TO SWITCH TO A DIFFERENT GLOVE.