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

Model Number REGULAR

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/14/2015

Event Type  malfunction  

Manufacturer Narrative

A document and records review was performed on the reported lot.Documentation assessed includes: manufacturing, quality audit, production, raw material and device history records.This assessment found no anomalies that may have attributed to the reported issue; therefore the complaint could not be confirmed.Complaint sample was not returned therefore a product evaluation could not be performed.The cause of the reported complaint could not be determined.Information from this incident will be included in our product complaint and mdr trend analysis.

Event Description

The consumer stated that two days after removal of tampon, she felt like something was still inside her.She stated she went to the doctor and the top part of the applicator that was removed.Consumer stated she is fine now.

• 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 Contact: angie masaro ; 2100 winchester rd.; neenah, WI 54956 ; 9207215934
• MDR Report Key: 5460687
• MDR Text Key: 39462347
• Report Number: 2381757-2016-00004
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK141294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REGULAR
• Device Lot Number: AC532766X0245
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2015
• 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: 41 YR