MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC L.TamponsOrgCottonFullSizeNaturalReg+SuperUnScnt18CT; Tampon, Menstrual, Unscented - HEB

Lot Number	500915051M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.
Event or Problem Description
When she removed it "[tampon]"¿top portion of the tampon was missing¿a fragment was left inside ¿ vagina "[foreign body in reproductive tract]".Top portion was missing/come apart during use - tampon "[device breakage]".Case narrative: consumer¿s parent stated via email that a fragment of the tampon was left inside the daughter during removal.No serious injury was reported.

• Brand Name: L.TamponsOrgCottonFullSizeNaturalReg+SuperUnScnt18CT
• 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: 25327806
• Report Number: 1219109-2026-00147
• Device Sequence Number: 9767570
• Product Code: HEB
• UDI-Device Identifier: 00073010721616
• UDI-Public: (01)00073010721616
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K081555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2026

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: 500915051M
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 07/30/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 07/21/2026; 08/25/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Female