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

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problems Bacterial Infection (1735); Fatigue (1849); Menstrual Irregularities (1959); Cramp(s) (2193); Intermenstrual Bleeding (2665); Device Embedded In Tissue or Plaque (3165)

Event Date 12/23/2018

Event Type  Injury  

Event Description

Tampon broke apart inside me; not sure how long inside me, ongoing vaginal bleeding, cramping and fatigue- went to doctor multiple times then found old tampon during pelvic exam and doctor removed.Developed a bacterial infection that required antibiotics.No longer have the tampon box but was a consumer of the product - didn't know about the lost tampon for 1-2+ months.

• Brand Name: U BY KOTEX REGULAR TAMPON
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORP.
• MDR Report Key: 8231566
• MDR Text Key: 132908217
• Report Number: MW5082986
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 72