MAUDE Adverse Event Report: KIMBERLY-CLARK CORP KOTEX PADS ; PAD, MENSTRUAL, UNSCENTED

Device Problems Device Emits Odor (1425); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Burning Sensation (2146)

Event Date 02/01/2019

Event Type  Injury  

Event Description

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.

• Brand Name: KOTEX PADS
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORP
• MDR Report Key: 8371823
• MDR Text Key: 137368153
• Report Number: MW5084389
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/01/2019
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 55 YR
• Patient Weight: 101