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 Number: MW5015202
• MDR Report Key: 1637306
• Date Received: 2010-03-17
• Date of Report: 2010-03-17
• Date of Event: 2010-03-11
• Date Added to Maude: 2010-03-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ALWAYS OVERNIGHT EXTRA HEAVY FLO
• Generic Name: NONE
• Product Code: HHD
• Date Received: 2010-03-17
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: P & G

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2010-03-17