MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION KOTEX CLICK CONNECT TAMPONS; TAMPON, MENSTRUAL, UNSCENTED

Lot Number NN225113B

Device Problems Material Fragmentation (1261); Material Split, Cut or Torn (4008)

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

Event Date 03/14/2023

Event Type  malfunction  

Event Description

I have had multiple tampons with kotex click connect regular size from multiple different boxes over several months with the click connect shred apart inside of me and the invalid detach from the shredding.I thought this issue was solved in 2019? clearly the issue is still happening.The tampon pulls out but you can feel it shredding to where you have to pull the stuffing out carefully hoping nothing is left behind.This is dangerous! and scary for the customer.I have lot number should someone need that.It does tend to happen when the tampon is slightly dry.But it shouldn't be happening period.I wasn't able to save the product as i was not home when it happened.

• Brand Name: KOTEX CLICK CONNECT TAMPONS
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION
• MDR Report Key: 16573697
• MDR Text Key: 311679451
• Report Number: MW5115823
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: NN225113B
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White