MAUDE Adverse Event Report: KIMBERLY CLARK CORP. TAMPON U BY KOTEX; PAD, MENSTRUAL, UNSCENTED

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/09/2019

Event Type  malfunction  

Event Description

A u by kotex tampon came apart as i removed it and pieces were left behind, inside of me.I've never noticed this issue before and looking it up have come to realize there were other multiple reports and issues.The box of tampons was purchased more recently and i am unsure i can get a refund.Fda safety report id# (b)(4).

• Brand Name: TAMPON U BY KOTEX
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY CLARK CORP.
• MDR Report Key: 8509099
• MDR Text Key: 141915738
• Report Number: MW5085811
• Device Sequence Number: 1
• Product Code: HHD
• UDI-Device Identifier: 00500000038603
• UDI-Public: 500000038603
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/09/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 64