FDA.reportPublic FDA data

MAUDE MDR 2236767

MDR report key
2236767
Report number
1423537-2011-00071
Event key
0
Event type
3
Date of event
2011-02-01
Date received
2011-09-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHELE DONATICH
Address
1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US
Phone
847-847-8478
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GLV EXAM ESTEEM SYN PF(VYL) MDGLOVE, PATIENT, EXAMINATION, VINYLLYZ8882NO LOT GIVEN* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-09-0701. O

Event Narratives#

D

Patient 1

NURSE HAS HAD REDNESS, PUFFINESS, ITCHING AND WEEPING/DRAINING AT TIMES TO HER KNUCKLES AND HANDS. SHE HAS HAD AN ONGOING IRRITATION FOR NINE MONTHS. SHE IS IN LONG CASES FOR UP TO TEN HOURS. THE SURGICAL SCRUB SHE USES MAY ALSO BE A FACTOR. SHE WAS SEEN BY A DERMATOLOGIST WHO PRESCRIBED STEROID CREAM.

N

Patient 1

CARDINAL HEALTH IS FILING THIS AS THE IMPORTER. THE CUSTOMER DID NOT PROVIDE THE SAMPLE OR THE LOT NUMBER. THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. THE POTENTIAL ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER A SMALL PERCENTAGE OF THE POPULATION MAY EXPERIENCE AN ALLERGY TO SOME OF THE CHEMICALS WHICH MAY BE ADDED DURING THE MANUFACTURING PROCESS. SOME REACTIONS MAY BE CAUSED BY CONTACT DERMATITIS AND MAY NOT BE ALLERGIC IN NATURE AT ALL. THE SUPPLIER WAS APPRISED OF THE COMPLAINT AND WILL CLOSELY MONITOR THE MANUFACTURING PROCESS. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.