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

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 02/19/2023

Event Type  malfunction  

Manufacturer Narrative

A brand name, model, udi or manufacturer lot code were not provided.With no means to determine the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.

Event Description

Consumer reported via e-mail that upon removal, an unspecified number of tampons unraveled and fell apart.She manually confirmed no pledget pieces remained in her vaginal cavity.Multiple attempts have been made to obtain further information regarding the consumer¿s use of the product and outcome; however, no further information has been received.

• Brand Name: U BY KOTEX UNKNOWN : 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: 16497724
• MDR Text Key: 310825641
• Report Number: 3003701733-2023-00001
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2023

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2023
• Initial Date FDA Received: 03/07/2023
• 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 Sex: Female