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

Model Number REGULAR

Device Problem Material Separation (1562)

Patient Problems Bacterial Infection (1735); Fever (1858); Rash (2033); Abnormal Vaginal Discharge (2123); Fungal Infection (2419)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.

Event Description

Consumer reported upon removal the string came apart from the tampon leaving the tampon lodged inside her.She manually removed the tampon and it came out in pieces.She experienced fever, face redness, hives, vaginal discharge, foul odor, and flu-like symptoms.Consumer thought she had tss and sought medical attention.Doctors confirmed she did not have tss.She was diagnosed with yeast infection, strep b, and bacterial vaginosis.She continues to experience symptoms and recurring yeast infections and doctors are concerned tampon pieces may have remained inside her.

• Brand Name: U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION; 2100 winchester rd.; neenah WI 54956
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION; 2100 winchester rd.; neenah WI 54956
• Manufacturer Contact: chris maertz ; 2100 winchester rd; neenah, WI 54956 ; 9207214907
• MDR Report Key: 9153354
• MDR Text Key: 161377654
• Report Number: 3003701733-2019-00777
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00036000998399
• UDI-Public: 00036000998399
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/03/2019

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: Lay User/Patient
• Device Model Number: REGULAR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 32 YR