ALWAYS SANITARY NAPKIN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-09 for ALWAYS SANITARY NAPKIN manufactured by .

Event Text Entries

[1899155] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5019379
MDR Report Key1990010
Date Received2011-02-09
Date of Report2011-02-09
Date Added to Maude2011-02-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALWAYS SANITARY NAPKIN
Generic NameSANITARY NAPKIN
Product CodeHHD
Date Received2011-02-09
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other 2011-02-09

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