MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TampaxTamponsBaseOEFOpenEndedRegNorUnScnt40CT; Tampon, Menstrual, Unscented - HEB

Lot Number	52832430374021:58
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	Malfunction
Additional Manufacturer Narrative
There is insufficient information to perform an investigation.
Event or Problem Description
Tampon stayed inside - vagina \"[foreign body in reproductive tract]\" tried to remove \"[tampon]\".The string came off in my hand \"[complication of device removal]\" string came off - tampon \"[device breakage]\".Case narrative: consumer reported via e-mail that tampon string came off during removal.No serious injury was reported.
Additional Manufacturer Narrative
15-jul-2026 no failure could be identified as a result of the investigation.
Event or Problem Description
Tampon stayed inside - vagina \"[foreign body in reproductive tract]\" ,\ tried to remove \"[tampon]\".The string came off in my hand \"[complication of device removal]\" ,\ string came off - tampon \"[device breakage]\".\ \ case narrative: consumer reported via e-mail that tampon string came off during removal.No serious injury was reported.\ \ follow-up 02-jun-2026: product return was received on 26-may-2026.Product investigation was in progress, conclusion not yet available.No serious injury was reported.\ \ follow-up 30-jun-2026: suspect product batch/lot number updated.No serious injury was reported.\ \ follow-up 15-jul-2026: no manufacturing was cause identified based on investigation.No serious injury was reported.

• Brand Name: TampaxTamponsBaseOEFOpenEndedRegNorUnScnt40CT
• 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: 25275719
• Report Number: 1219109-2026-00135
• Device Sequence Number: 13057670
• Product Code: HEB
• UDI-Device Identifier: 00073010221109
• UDI-Public: (01)00073010221109
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K061486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/04/2026

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: 52832430374021:58
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; 07/15/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/19/2026; 07/17/2026; 08/06/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female