MAUDE MDR 1990010

MDR report key
1990010
Report number
MW5019379
Event key
0
Event type
3
Date received
2011-02-09
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
1ALWAYS SANITARY NAPKINSANITARY NAPKINHHD

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-0901. L; 2. O

Event Narratives#

D

Patient 1

TO WHOM IT MAY CONCERN, IT IS MY UNDERSTANDING THAT YOU ARE CURRENTLY CONSIDERING PLACING WARNINGS ON BOXES OF POWDERED LATEX GLOVES. I URGE YOU TO DO SO. MY SON, (B)(6) AND I HAVE BOTH BEEN DIAGNOSED WITH LATEX ALLERGY IN THE PAST YR AND A HALF. NEITHER OF US ARE HEALTHCARE WORKERS NOR HAVE SPINA BIFIDA. I WORKED FOR A BRIEF TIME IN FOOD SERVICE IN MY EARLY 20'S BUT HAVE NOT HELD JOBS, THAT I REMEMBER, WHERE I WAS SIGNIFICANTLY EXPOSED. I WAS DIAGNOSED AFTER PROGRESSIVELY WORSENING REACTIONS TO A MAINSTREAM BRAND OF SANITARY NAPKINS AND THANKFULLY THOSE REACTIONS STOPPED WHEN I SWITCHED TO A BRAND THAT IS LISTED ON THE LATEX-FREE LISTS PROVIDED BY VARIOUS ORGANIZATIONS AND ASSOCIATIONS. YRS AGO, I HAD TRANSIENT SKIN IRRITATION AND RASHES AFTER USING RUBBER GLOVES FOR DISH WASHING. I NOW HAVE TYPE 1 LATEX ALLERGY REACTIONS/SYMPTOMS. I URGE YOU TO PLACE WARNINGS ON THE GLOVES BECAUSE POWDERED LATEX GLOVE USE HAS DELAYED MY MEDICAL CARE. I RECENTLY ASKED AN ENDOCRINOLOGIST TO RE-EVALUATE ME FOR TYPE 1 DIABETES BUT BECAUSE OF POWDERED GLOVE USE, AND LACK OF UNDERSTANDING OF THIS ALLERGY AND THE RISKS THAT POWDERED GLOVES POSE, I HAVE HAD TO EDUCATE THEIR OFFICE AND ADVOCATE FOR MYSELF AND DELAY TREATMENT UNTIL ACCOMMODATIONS COULD BE MADE. AS IT IS, I STILL AM NOT ABLE TO GET LABWORK DONE IN THEIR OFFICE AND HAVE TO USE MY PRIMARY CARE'S OFFICE LAB, ALL BECAUSE OF POWDERED GLOVE USE AND THE CROSS-CONTAMINATION THAT COMES WITH IT.