MAUDE Adverse Event Report: Essity HMS North America Inc Playtex Sport Regular Unscented 36 Count; Tampon

Lot Number	26015BB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The consumer stated the tampon failed, and upon removal strings broke while product remained inserted.Urgent care visit required for removal.

• Brand Name: Playtex Sport Regular Unscented 36 Count
• 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: 50884292
• Report Number: 2515444-2026-70044
• Device Sequence Number: 9799618
• Product Code: HEB
• UDI-Device Identifier: 00078300099222
• UDI-Public: 00078300099222
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/24/2026

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
• Device Lot Number: 26015BB
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2026
• 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: 38 YR
• Patient Sex: Unknown