MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TampaxTamponsPearlFullSizeReg,Super,SuperPlusUnScnt47CT; Tampon, Menstrual, Unscented - HEB

Lot Number	6189243045 14 23:11
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	Serious Injury
Event or Problem Description
Pain - vagina "[vulvovaginal pain]".String popped completely.Tampon was finally able to be removed - vagina "[foreign body in reproductive tract]".While removing "[tampon]" string popped completely off with the lightest little tug¿with a lot of pain¿finally able to be removed "[complication of device removal]".String popped completely off with the lightest little tug - tampax "[device breakage]".Case narrative: consumer reporter via messaging that tampon string popped completely off with the lightest little tug.No serious injury was reported.
Additional Manufacturer Narrative
Product investigation is in progress.

• Brand Name: TampaxTamponsPearlFullSizeReg,Super,SuperPlusUnScnt47CT
• 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: 50879522
• Report Number: 1219109-2026-00258
• Device Sequence Number: 13450545
• Product Code: HEB
• UDI-Device Identifier: 00073010718302
• UDI-Public: (01)00073010718302
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/22/2026

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: 6189243045 14 23:11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/24/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female