MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION U BY KOTEX CLICK COMPACT REGULAR TAMPON; PAD, MENSTRUAL, UNSCENTED

Catalog Number 3600051586 (BARCODE)

Device Problem Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2021

Event Type  malfunction  

Event Description

When using a u by kotex click compact tampon, it unraveled as i was pulling it out.It was if the sides of the tampons were stuck inside me, but the center pulled out.I had been wearing it for approximately 6 hrs on the third day of my mensural cycle.Fda safety report id # (b)(4).

• Brand Name: U BY KOTEX CLICK COMPACT REGULAR TAMPON
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION
• MDR Report Key: 12307725
• MDR Text Key: 266302271
• Report Number: MW5103165
• 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: 08/09/2021

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3600051586 (BARCODE)
• Device Lot Number: 500000050670 (ABOVE BAR CODE)
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 88