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

Lot Number AC512666X133

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

Device history record is under review.Information from this incident will be included in our product complaint and mdr trend analysis.Consumer had not returned unused product for evaluation at the time of this report.

Event Description

Consumer experienced an odor and slight discharge she stated she had found a piece of the tampon that was lodged inside, she was able to retrieve it.

• 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: jean nielsen ; 2100 winchester rd.; neenah 54956 ; 9207216517
• MDR Report Key: 5071376
• MDR Text Key: 26048535
• Report Number: 2381757-2015-00043
• 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
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: AC512666X133
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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