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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Urinary Tract Infection (2120)

Event Date 01/01/2019

Event Type  Injury  

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

The information provided indicated the consumer reported she had many uti infections and was even hospitalized for a bacterial infection because of the tampon.

• 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: chris maertz ; 2100 winchester rd; neenah, WI 54956 ; 9207214907
• MDR Report Key: 8899413
• MDR Text Key: 154540230
• Report Number: 3003701733-2019-00549
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2019
• 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 Outcome(s): Hospitalization