ALWAYS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-01-31 for ALWAYS manufactured by Procter & Gamble Co.

Event Text Entries

[253050] The consumer reported that they had an unusual experience when opening an "always" thin pad (sanitary napkin). When they opened the product last evening. They said it exhibited a very strong, toxic-like odor and that it contained powder. Consumer said it appears that someone intentionally put the substance in the product. Consumer purchased the product last month. One box contains two packages of 36 individually packaged pads. They stated that one package has 18 remaining and the other has 21 remaining. Consumer has been using this brand of product for years and they have never encountered anything like this. Consumer contacted the mfr and they told them it could be a manufacturing problem. They asked consumer to mail the product to them. Consumer said they are concerned about toxins and are worried they will not tell them what is in the product. Consumer would like to have it tested. Referred to 911. Consumer said it was not an emergency, they were just concerned about their health. Additionally, the product has been stored in the bathroom and consumer is worried about the health of their children. The complainant said they developed a headache within 10 minutes of opening the product. It lasted until they went to bed at 11:00 pm. They said they were fine this morning.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003185
• MDR Report Key: 375710
• Date Received: 2002-01-31
• Date of Report: 2002-01-31
• Date of Event: 2001-12-01
• Date Added to Maude: 2002-02-11
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ALWAYS
• Generic Name: ULTRA THIN PADS
• Product Code: HHL
• Date Received: 2002-01-31
• Model Number: NA
• Catalog Number: NI
• Lot Number: 13204786650224
• ID Number: NI
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 364798
• Manufacturer: PROCTER & GAMBLE CO
• Manufacturer Address: 5348 VINE ST CINCINNATI OH 45217 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-01-31