MAUDE Adverse Event Report: KIMBERLY-CLARK CORP. KOTEX TAMPON; TAMPON, MENSTRUAL, UNSCENTED

Lot Number	AC823126X2255
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Kotex u regular (non-slim) tampon manufacturer defect.When removing a tampon this morning, a piece (approx 1 inch) of a tampon fell into the toilet.The piece may be from a day or two ago.This is a non-slim regular tampon.

• Brand Name: KOTEX TAMPON
• Common Device Name: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORP.
• MDR Report Key: 8310645
• Report Number: MW5083726
• Device Sequence Number: 18870543
• Product Code: HEB
• UDI-Device Identifier: 00036000423372
• UDI-Public: 036000423372
• Combination Product (Y/N): N
• 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): 02/02/2019

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
• Operator of Device: Lay User/Patient
• Device Lot Number: AC823126X2255
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2019
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 59