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

Model Number REGULAR

Device Problem Material Fragmentation (1261)

Patient Problem Intermenstrual Bleeding (2665)

Event Date 08/01/2016

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 she went to insert a tampon and while pulling the applicator, a plastic piece came out from the tampon she inserted previous day.She stated plastic cut her vagina and caused bleeding.Multiple attempts have been made to obtain further information.No further information has been received.

• 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: emily arnould, rn bsn ; 2100 winchester rd; neenah, WI 54956 ; 9207213128
• MDR Report Key: 9596984
• MDR Text Key: 175252812
• Report Number: 3003701733-2020-00027
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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
• Date Manufacturer Received: 08/09/2016
• 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