FDA.reportPublic FDA data

MAUDE MDR 3365755

MDR report key
3365755
Report number
MW5031971
Event key
0
Event type
3
Date received
2013-09-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ANSELLVINYL-TOUCH GLOVESANSELLLYY13054088DF

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-09-180

Event Narratives#

D

Patient 1

CALLER COMPLAINED ABOUT A FOUL ODOR FROM THE ANSELL VINYL-TOCH GLOVES. THIS PRODUCT WHICH IS MADE IN CHINA EMITS A VERY STRONG AND FOUL ODOR AS SOON AS THE BOX IS OPENED. THE CALLER IS CONCERNED THAT THESE GLOVES COULD BE INFLAMMABLE OR THEY COULD BE A HEALTH HAZARD. HE STATED THAT HIS WIFE USES THE GLOVES FOR EVERY DAY HOUSE CHORES AND FOR BATHING AND FEEDING HER DAUGHTER. THE CALLER HAS CALLED THE MFR AND LEFT VOICE MESSAGES, BUT NOBODY HAS CALLED BACK. (B)(4).