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

Patient Problem Urinary Frequency (2275)

Event Date 03/24/2024

Event Type  Injury  

Event Description

Reporter called to submit a report regarding the adverse event she experienced using u-cotex menstrual pad.Reporter stated this is the second time she is experiencing adverse effects from this product.She said after wearing the pad, she was having uncontrollable urinary frequency.She said right after she urinated, she feels the urgency to go to the bathroom again.She said, she calls the manufacturer and reported her complaints with their product.Reference report #mw5153123.

• Brand Name: KOTEX
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION
• MDR Report Key: 18977704
• MDR Text Key: 338723320
• Report Number: MW5153122
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• 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: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2024
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American