MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSBASEOEFOPENENDEDSUPERPLUSUNSCNT40CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	5319243027 38 06:22
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product investigation is in progress.
Event or Problem Description
They (tampon) stayed retained in the body, got stuck but i was able to get it out- vagina [foreign body in reproductive tract] 6- 7 of the tampons, the string was attached in the wrong way¿incorrectly made, the string went the wrong way like the string was at the top [device physical property issue].Case narrative: consumer reported via phone that the tampon strings were attached in the wrong way.No serious injury reported.

• Brand Name: TAMPAXTAMPONSBASEOEFOPENENDEDSUPERPLUSUNSCNT40CT
• Common Device Name: TAMPON, MENSTRUAL, UNSCENTED - HEB
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn 04210
• Manufacturer (Section G): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn 04210
• Manufacturer Contact: manager affairs,feminine care ; winton hill business center b; 6280 center hill avenue; cincinnati 45224
• MDR Report Key: 24967103
• Report Number: 1219109-2026-00103
• Device Sequence Number: 10496658
• Product Code: HEB
• UDI-Device Identifier: 00073010421103
• UDI-Public: (01)00073010421103
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K061486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 5319243027 38 06:22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Female