MAUDE Adverse Event Report: ESSITY HMS NORTH AMERICA INC. PLAYTEX; SPORT REGULAR UNSCENTED TAMPON 36 COUNT

Lot Number	25233BB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Problem reported : the reporter stated that when their 17 yr old daughter was removing a tampon and the string came out without the tampon.When she tried to get the tampon, she couldn't.After 2 hours of trying, we went to the emrgency room.The doctor said that the tampon had migrated as far up as it possibly could go to the cervix.Needless to say, removing this with forceps was quite traumatic for a 17 year old girl who had not yet had her first ob/gyn exam.

• Brand Name: PLAYTEX
• Common Device Name: SPORT REGULAR UNSCENTED TAMPON 36 COUNT
• Manufacturer (Section D): ESSITY HMS NORTH AMERICA INC.; 804 walker rd; dover DE 19904
• Manufacturer (Section G): ESSITY HMS NORTH AMERICA INC; 804 walker rd; dover DE 19904
• Manufacturer Contact: drashti desai ; 5825 carnegie blvd; charlotte, NC 28209
• MDR Report Key: 24879778
• Report Number: 2515444-2026-70032
• Device Sequence Number: 10420193
• Product Code: HEB
• UDI-Device Identifier: 00078300099222
• UDI-Public: 00078300099222
• Combination Product (Y/N): N
• 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): 04/10/2026

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 25233BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: 17 YR
• Patient Sex: Female