FDA.reportPublic FDA data

MAUDE MDR 3650321

MDR report key
3650321
Report number
1423537-2014-00009
Event key
0
Event type
3
Date of event
2014-01-30
Date received
2014-02-27
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
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
1ESTEEM STRETCHY SYNTH CREAM LGLOVE, PATIENT EXAMINATION, VINYLCARDINAL HEALTHLYZ8883B9R13P052R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-02-2701. O

Event Narratives#

N

Patient 1

SAMPLES WERE RECEIVED AND THE LOT# WAS PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ABNORMALITIES WERE NOTED. HISTORICAL TRENDING WAS DONE. BASED ON THE RETURNED SAMPLES, THERE WAS NO SKIN IRRITATION WITH THE WEARING TEST. THERE HAS BEEN NO CHANGE IN THE FORMULATION OF THE GLOVE. THE SUPPLIER HAS BEEN APPRISED OF THIS REPORTED INCIDENT FOR CLOSE MONITORING OF THE MANUFACTURING PROCESS. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME AS WE ARE UNABLE TO IDENTIFY THE ROOT CAUSE. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS OF THIS NATURE.

N

Patient 1

CARDINAL HEALTH IS FILING THIS AS THE IMPORTER. THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY FOR INVESTIGATION. WE ARE AWAITING SAMPLE RETURN FROM THE CUSTOMER. WHEN SAMPLES ARE RECEIVED THEY WILL BE FORWARDED TO THE MANUFACTURING FACILITY FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE RESULTS OF INVESTIGATION ARE COMPLETED.

D

Patient 1

TWO NURSES BETWEEN THE AGES OF 25-35 DEVELOPED SKIN IRRITATION AND WERE SEEN BY THE INFECTION NURSE. THEY WERE GIVEN A CREAM (NAME NOT PROVIDED) AND DIFFERENT GLOVES WERE BOUGHT FOR THEM.