MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TampaxTamponsPearlFullSizeSuperUnScnt50CT; Tampon, Menstrual, Unscented - HEB

Lot Number	6140243005 68 06:42
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Small piece was stuck inside "[tampon]" - vagina "[foreign body in reproductive tract]" "[tampon]" tore "[device breakage]".Case narrative: consumer reported via email that tampon tore.No serious injury was reported.
Additional Manufacturer Narrative
Product investigation is in progress.

• Brand Name: TampaxTamponsPearlFullSizeSuperUnScnt50CT
• 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: 50726482
• Report Number: 1219109-2026-00249
• Device Sequence Number: 10600069
• Product Code: HEB
• UDI-Device Identifier: 00073010009226
• UDI-Public: (01)00073010009226
• 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): 09/10/2026

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: 6140243005 68 06:42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/11/2026
• 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 Sex: Female