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

Model Number REGULAR

Device Problem Material Separation (1562)

Patient Problems Bacterial Infection (1735); Itching Sensation (1943); Menstrual Irregularities (1959); Miscarriage (1962); Abnormal Vaginal Discharge (2123)

Event Date 11/01/2018

Event Type  Injury  

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

The consumer stated that a tampon came apart upon removal and tampon pieces remained inside of her.She sought medical assistance.She was diagnosed with a yeast infection and was prescribed antibiotics.She experienced vaginal discharge, itch and bleeding.She was later diagnosed with a bacterial infection and was prescribed a two week antibiotic.During the time of the infection the consumer stated that she suffered a miscarriage.

• Brand Name: U BY KOTEX CLICK
• 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: marian vargas ; 2100 winchester rd; neenah, WI 54956 ; 9207215889
• MDR Report Key: 8242073
• MDR Text Key: 132905370
• Report Number: 3003701733-2019-00037
• 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: K113036
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REGULAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2018
• 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 Outcome(s): Other
• Patient Age: 28 YR