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

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  Injury  

Event Description

U by kotex click with comfort flex tampon (regular 48 count box) fell apart while i tried to remove it.Have to go to the doctor to make sure it all got out safely.

• Brand Name: U BY KOTEX
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION
• MDR Report Key: 12814504
• MDR Text Key: 280902579
• Report Number: MW5105318
• 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
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White