MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC L.TAMPONSORGCOTTONFULLSIZENATURALREG+SUPERUNSCNT42CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	5251D541115268
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
Unable to get tampon out - vagina [foreign body in reproductive tract].String on tampon disintegrated and broke off into 4 tiny little pieces [device breakage].Case narrative: consumer reported via email that the tampon string disintegrated and broke off.No serious injury was reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.
Event or Problem Description
Unable to get tampon out - vagina [foreign body in reproductive tract] string on tampon disintegrated and broke off into 4 tiny little pieces [device breakage].Case narrative: consumer reported via email that the tampon string disintegrated and broke off.No serious injury was reported.

• Brand Name: L.TAMPONSORGCOTTONFULLSIZENATURALREG+SUPERUNSCNT42CT
• 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: 23803904
• Report Number: 1219109-2025-00371
• Device Sequence Number: 21179595
• Product Code: HEB
• UDI-Device Identifier: 00073010716520
• UDI-Public: (01)00073010716520
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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): 12/26/2025

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: 5251D541115268
• Was Device Available for Evaluation?: No
• 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: 12/15/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 25 YR
• Patient Sex: Female