MAUDE Adverse Event Report: Essity HMS North America Inc. Playtex; Tampon

Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter describes the incident with tampon, where the inserted tampon string was detached without any rips or tears and she already was experiencing vaginismus which made repested attempts at self-removal painful and unsuccessful.She had to go emergency room to get it removed by medical staff.

• Brand Name: Playtex
• Common Device Name: Tampon
• Manufacturer (Section D): Essity HMS North America Inc.; 804 walker rd; dover DE 19904
• Manufacturer Contact: vicki heath ; 804 walker rd; dover, DE 19904
• MDR Report Key: 50015885
• Report Number: 2515444-2026-70038
• Device Sequence Number: 13199533
• Product Code: HEB
• UDI-Device Identifier: 00078300081111
• UDI-Public: 00078300081111
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K132819
• 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): 07/24/2026

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?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 20 YR
• Patient Sex: Female