MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZEULTRAUNSCNT18CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	53042430084315:43
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
No failure could be identified as a result of the investigation.
Event or Problem Description
Concerned i may end up with stuff stuck up in my female part the way the cotton is coming apart on these.Douche to make sure cotton was out of my area- vagina [foreign body in reproductive tract].Tampons are falling apart [device breakage].Case narrative: consumer reported via e-mail that the tampons are falling apart.No serious injury reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.
Event or Problem Description
Concerned i may end up with stuff stuck up in my female part the way the cotton is coming apart on these.Douche to make sure cotton was out of my area- vagina [foreign body in reproductive tract].Tampons are falling apart [device breakage].Case narrative: consumer reported via e-mail that the tampons are falling apart.No serious injury reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the lot code investigation, completed on 24 feb 2026.An investigation is in progress for returned product received on 01 apr 2026.
Event or Problem Description
Concerned i may end up with stuff stuck up in my female part the way the cotton is coming apart on these.Douche to make sure cotton was out of my area - vagina [foreign body in reproductive tract].Tampons are falling apart [device breakage].Case narrative: consumer reported via e-mail that the tampons are falling apart.No serious injury reported.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZEULTRAUNSCNT18CT
• 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: 24451974
• Report Number: 1219109-2026-00045
• Device Sequence Number: 15779043
• Product Code: HEB
• UDI-Device Identifier: 00073010009868
• UDI-Public: (01)00073010009868
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K081555
• 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,Followup
• Report Date (Section B): 05/14/2026

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: 53042430084315:43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/27/2026
• 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 Age: 48 YR
• Patient Sex: Female