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

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/05/2021

Event Type  Injury  

Event Description

Use a regular tampon (b)(6) when removing the tampon some tampon remained.Had to pull separate pieces of tampon out.Fda safety report id # (b)(4).

• Brand Name: U BY KOTEX TAMPON
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION
• MDR Report Key: 12787525
• MDR Text Key: 280749174
• Report Number: MW5105237
• 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: 11/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White