MAUDE Adverse Event Report: KIMBERLYCLARK KOTEX; PANTILINERS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Rash (2033); Burning Sensation (2146); Ambulation Difficulties (2544)

Event Date 08/10/2014

Event Type  Injury  

Event Description

I have been using pads and pantiliners for the past 10 years and i have always had issues with pain, burning, itching, and bad rashes when using any major pad or pantiliner product such as always and kotex.I finally did my research after the pain and burning got so bad it hurt to walk.I learned that there is sulfur in the pads and pantiliners and i am allergic to it.My doctor confirmed this and i have since stopped using this products and found all organic ones with no sulfur whatsoever and have been fine.

• Brand Name: KOTEX
• Type of Device: PANTILINERS
• Manufacturer (Section D): KIMBERLYCLARK
• MDR Report Key: 4085152
• MDR Text Key: 4894089
• Report Number: MW5038151
• Device Sequence Number: 1
• Product Code: HHD
• 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: 09/08/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 21 YR
• Patient Weight: 82