MAUDE Adverse Event Report: Essity HMS North America Inc o.b. Original Ultra Unscented Tampons 40 Count

Lot Number	2039403
Medical Device Problem Codes	Material Fragmentation (1261); Unraveled Material (1664)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The consumer stated they thought the tampons had changed.They found the tampons to feel hard and painful when they used to feel comfortable.The consumer indicated they had been finding that the tampons unravel upon removal.In this instance the consumer stated the tampon unraveled upon removal and they were visiting a doctor to assist with the removal of a piece of tampon retained in their body.The consumer noted they believed the retained piece was causing an infection.Upon visiting the ob-gyn the consumer indicated fibers were removed and antibiotics were prescribed.

• Brand Name: o.b. Original Ultra Unscented Tampons 40 Count
• Common Device Name: Tampon
• Manufacturer (Section D): Essity HMS North America Inc; 804 walker rd; dover DE 19904
• Manufacturer Contact: vicki heath ; hygieneartikel, deutschland gmbh, fabrikstrasse 30; großpostwitz D-026-92 ; GM D-02692
• MDR Report Key: 50500182
• Report Number: 2515444-2026-70043
• Device Sequence Number: 21197080
• Product Code: HEB
• UDI-Device Identifier: 00078300021797
• UDI-Public: 00078300021797
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K990536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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?: No
• Device Lot Number: 2039403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female