KOTEX PADS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for KOTEX PADS manufactured by Kimberly-clark Corp.

Event Text Entries

[137368153] I purchased some food at a food bar, inside the store and bought feminine hygiene products: maxi pads. I smelled a foul distinct odor outside the store and it continued inside the store, but that was just the start. Regardless of this stench, the products were maliciously contaminated at the manufacturing plant and then distributed. I am talking about the maxi pads by kotex. They burn the skin in the female area, the fumes move up so that you can smell it from the pad, it is not my smell i am menopausal. I sue them for incontinence/bladder protection because they are more affordable. There seems to be some chemical combination going on making it when urine combined or not there is a really disgusting smell, human biological hormonal shell. It is really disgusting and the smell traits and gets all over your clothes. I would like to know the chemical composition of what is on these pads. Frequency daily. How was it taken or used topical. Why was the person using the product? (such as what condition was it supposed to treat) bladder protection.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5084389
• MDR Report Key: 8371823
• Date Received: 2019-02-26
• Date of Report: 2019-02-23
• Date of Event: 2019-02-01
• Date Added to Maude: 2019-02-26
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: KOTEX PADS
• Generic Name: PAD, MENSTRUAL, UNSCENTED
• Product Code: HHD
• Date Received: 2019-02-26
• Device Expiration Date: 2019-02-01
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KIMBERLY-CLARK CORP

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Other; 3. Deathisabilit	2019-02-26