MAUDE Adverse Event Report: KIMBERLY - CLARK CORP. CONWAY MILL KOTEX; PAD, MENSTRUAL

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 03/01/2019

Event Type  No Answer Provided  

Event Description

Kotex daily liners are coming apart with each use which is dangerous and unsanitary.Please see the complaints and pictures on their own comments page and they aren't addressing 'itz'.I bought two boxes so i still have them.I contacted kotex without any response.(b)(4).

• Brand Name: KOTEX
• Type of Device: PAD, MENSTRUAL
• Manufacturer (Section D): KIMBERLY - CLARK CORP. CONWAY MILL
• MDR Report Key: 8491823
• MDR Text Key: 141318824
• Report Number: MW5085637
• 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: 03/27/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR