ALWAYS OVERNIGHT EXTRA HEAVY FLO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-17 for ALWAYS OVERNIGHT EXTRA HEAVY FLO manufactured by P & G.

Event Text Entries

[1331881] I went in for surgery on 3-15 and told my doctor that i had a huge rash all over my bottom-painful blisters. I wanted her to know since she was doing the uterine ablation surgery. She asked me right away which maxi sanitary brands i was using and i told her always. She told me to stay away from always brand because they contain formaldehyde. Researching that i found it to be very scary. It has been almost a week and the rash is still there. I looked over the package and there is nothing on it that states formaldehyde is used as a drying agent. As a consumer shouldn't we be made aware that this scary chemical is used as a drying agent on our women personals? Nothing is printed on the package suggesting any chemicals are used. I have used always brand for years and never had this problem until i used always overnight protection -extra heavy flow pads-upc (b) (4). Dose or amount: 1. Frequency: per need. Route: vag. Dates of use: (b) (6) 2010 - (b) (6) 2010. Diagnosis or reason for use: heavy periods. Event abated after use stopped: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5015202
MDR Report Key1637306
Date Received2010-03-17
Date of Report2010-03-17
Date of Event2010-03-11
Date Added to Maude2010-03-26
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 OVERNIGHT EXTRA HEAVY FLO
Generic NameNONE
Product CodeHHD
Date Received2010-03-17
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerP & G


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-03-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.