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

Model Number SUPER PLUS

Device Problem Material Separation (1562)

Patient Problems Bacterial Infection (1735); Itching Sensation (1943); Swelling (2091); Burning Sensation (2146)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the (malfunction or reported issue).

Event Description

Consumer reported that the string pulled out of the tampon during removal and required assistance from her husband to manually remove the tampon out.Consumer also mentioned string being short with some tampons and one tampon fell apart into pieces during removal.Consumer experienced yeast infection, swelling, burning itchy and redness to vaginal area.Consumer visited doctor and the doctor confirmed that the yeast infection is due to the tampons and advised her not to use the tampons anymore.Multiple attempts made to obtain further information regarding consumer's wellness check however no further information has been received.

• 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 7191
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION - CONWAY MILL; 480 exchange ave.; conway AR 72032 7191
• Manufacturer Contact: emily arnould, rn bsn ; 2100 winchester rd; neenah, WI 54956 ; 9207213128
• MDR Report Key: 9466257
• MDR Text Key: 170744878
• Report Number: 2381757-2019-00450
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00036000998443
• UDI-Public: 00036000998443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141294
• 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: 12/13/2019

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: SUPER PLUS
• Device Lot Number: AC818922X1135
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2018
• 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 Age: 25 YR