MAUDE Adverse Event Report: KIMBERLY-CLARK CORP. U BY KOTEX SLEEK TAMPON, REGULAR; TAMPON, MENSTRUAL

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Tampon completely fell apart and shredded upon removal.

• Brand Name: U BY KOTEX SLEEK TAMPON, REGULAR
• Common Device Name: TAMPON, MENSTRUAL
• Manufacturer (Section D): KIMBERLY-CLARK CORP.
• MDR Report Key: 8169623
• Report Number: MW5082176
• Device Sequence Number: 11095927
• Product Code: HEB
• UDI-Device Identifier: 00036000426649
• UDI-Public: 036000426649
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2018
• Patient Sequence Number: 1
• Patient Age: 32 YR