MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION U BY KOTEX CLICK REGULAR; TAMPON, MENSTRUAL, UNSCENTED

Lot Number NN202413A

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

We were using kotex tampons, upon removal of tampon from body, we noticed fragments were left behind and the tampon was unraveling inside the vagina.

• Brand Name: U BY KOTEX CLICK REGULAR
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION
• MDR Report Key: 14236192
• MDR Text Key: 290377808
• Report Number: MW5109403
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: NN202413A
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White