MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT50CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	601224302769
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)
Type of Reportable Event	Malfunction
Event or Problem Description
Tampon got stuck in vagina [foreign body in reproductive tract].Stretch myself vagina [vulvovaginal injury].Hurt vagina [vulvovaginal pain].Hurt taking tampon out [complication of device removal].(tampon got stuck in vagina) and when i went to pull it out.It was only the string [device breakage].Case narrative: consumer reported via phone that the tampon got stuck in her vagina and only the string came out.No serious injury reported.
Additional Manufacturer Narrative
Product investigation is in progress.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT50CT
• 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: 24860833
• Report Number: 1219109-2026-00088
• Device Sequence Number: 18764073
• Product Code: HEB
• UDI-Device Identifier: 00073010711242
• UDI-Public: (01)00073010711242
• 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
• Report Date (Section B): 06/05/2026

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: 601224302769
• Was Device Available for Evaluation?: No
• 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
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 06/08/2026
• 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: 26 YR
• Patient Sex: Female