MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZEULTRAUNSCNT45CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	5174243013 43 08:24
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
(pieces of the tampon are now ripping off).Getting left behind- vagina [foreign body in reproductive tract].Pieces of the tampon are now ripping off when i pull it out and getting left behind [complication of device removal].Pieces of the tampon are now ripping off [device breakage].Case narrative: consumer reported via e-mail that pieces of the tampon are ripping off.No serious injury reported.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZEULTRAUNSCNT45CT
• 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: 24647914
• Report Number: 1219109-2026-00077
• Device Sequence Number: 15994589
• Product Code: HEB
• UDI-Device Identifier: 00073010714410
• UDI-Public: (01)00073010714410
• 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): 04/30/2026

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: 5174243013 43 08:24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• 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: 03/20/2026
• Supplement Report FDA Received Date: 05/05/2026
• 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: 39 YR
• Patient Sex: Female