MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION U KOTEX TAMPONS POCKET SIZE; PAD, MENSTRUAL, UNSCENTED

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problems Bacterial Infection (1735); Pain (1994)

Event Date 11/25/2020

Event Type  Injury  

Event Description

The tampon many out of that package fell apart upon removal and later had to go to a doctor for pain and odor to find half a tampon stuck causing infection and continuing to get worse i have missed work had to pay out of pocket without health insurance right now to see doctors and pay for prescriptions and i still have a second round of vaginal antibiotics to endure.I am very upset due to having to be put through seeing a doctor for this issue and having to miss out in a new job due to the side effects of this tampon.(b)(6).Fda safety report id # (b)(4).

• Brand Name: U KOTEX TAMPONS POCKET SIZE
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION
• MDR Report Key: 11019096
• MDR Text Key: 222080090
• Report Number: MW5098394
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): Y
• 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: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 66