MAUDE Adverse Event Report: KIMBERLY CLARK CORP. U BY KOTEX SLEEK TAMPONS

Device Problem Material Separation (1562)

Patient Problems Fainting (1847); Fatigue (1849); Fever (1858); Headache (1880); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Abnormal Vaginal Discharge (2123); Vomiting (2144); Anxiety (2328); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 12/12/2018

Event Type  Injury  

Event Description

I always purchases this brand of tampon, never had a problem until now.For a week now i've been getting horrible headaches, fever, throwing up, low blood pressure and sleeping all day waking up just to go to work and come back to bed.I kept getting what i thought was anxiety attacks where i couldn't really breathe and felt like i was going to pass out.Now i'm thinking that it might have been some form of toxic shock.Today i showered and noticed a horrible odor and began to clean myself and found brown discharge and a piece of tampon inside of me.I was on my menstrual cycle.Other serious / important medical incident: had to go to urgent.

• Brand Name: U BY KOTEX SLEEK TAMPONS
• Type of Device: U BY KOTEX SLEEK TAMPONS
• Manufacturer (Section D): KIMBERLY CLARK CORP.
• MDR Report Key: 8164844
• MDR Text Key: 130507117
• Report Number: MW5082146
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR