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

Device Problem Component Missing (2306)

Patient Problems Bacterial Infection (1735); Pain (1994); Intermenstrual Bleeding (2665)

Event Date 10/08/2018

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 string missing from the tampon because of which she never realized that there was a tampon inside of her.Consumer experienced bleeding and bad odor and pain that continued to travel back to her back and legs.Consumer visited er and found a tampon was inside her.Emergency room performed pap test and she had results with positive bacteria in the vagina.Consumer was prescribed medication for 5 days and is feeling better.

• 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: 9466290
• MDR Text Key: 174693681
• Report Number: 3003701733-2019-00865
• 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: 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/13/2019
• 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: 46 YR