MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TampaxTamponsRadiantRadiantRegNorUnScnt42CT; Tampon, Menstrual, Unscented - HEB

Lot Number	60662430236722:31
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is insufficient information to perform an investigation.
Event or Problem Description
Leaving the tampon inside - vagina "[foreign body in reproductive tract]".While removing a tampon, the string detached completely, leaving the tampon inside - vagina "[complication of device removal]"."[tampon]" string detached completely "[device breakage]".Case narrative: consumer reported via email that the tampon string detached completely during removal.No serious injury was reported.

• Brand Name: TampaxTamponsRadiantRadiantRegNorUnScnt42CT
• 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: 25714992
• Report Number: 1219109-2026-00171
• Device Sequence Number: 5118425
• Product Code: HEB
• UDI-Device Identifier: 00073010716292
• UDI-Public: (01)00073010716292
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K110669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/28/2026

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: 60662430236722:31
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2026
• 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; 07/16/2026; 08/07/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 07/16/2026; 08/06/2026; 08/31/2026
• 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: 24 YR
• Patient Sex: Female