MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION - CONWAY MILL U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB

Model Number SUPER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nausea (1970); Dizziness (2194)

Event Date 03/01/2015

Event Type  Injury  

Event Description

An hour to an hour and a half after inserting a tampon she felt dizzy and nauseous and thought she was going to throw up.She might have had a head ache but she isn't sure.No fever or any other symptom.She removed the tampon immediately after noticing her symptoms.It took her a while after removing to feel better, but she is fine now.

Manufacturer Narrative

Device history record is under review.Information from this incident will be included in our product complaint and mdr trend analysis.Consumer had not returned unused product for evaluation at the time of this report.

• Brand Name: U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION - CONWAY MILL; 480 exchange ave.; conway AR 72032 719
• Manufacturer Contact: jean nielsen ; 2100 winchester rd.; neenah, WI 54956 ; 9207216517
• MDR Report Key: 4649705
• MDR Text Key: 21238589
• Report Number: 2381757-2015-00010
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK141294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SUPER
• Device Lot Number: AC430427X2316
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR