MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSRADIANTRADIANTSUPERPLUSUNSCNT28CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	5023243050 47 23:57
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
Half a tampon retained- vagina [foreign body in reproductive tract].Cotton is falling apart- tampon [device breakage].Half a tampon retained, cotton is falling apart when trying to remove the remaining pieces [complication of device removal].Case narrative: consumer reported via phone that cotton is falling apart during removal.No serious injury reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.
Event or Problem Description
Half a tampon retained- vagina [foreign body in reproductive tract] cotton is falling apart- tampon [device breakage] half a tampon retained, cotton is falling apart when trying to remove the remaining pieces [complication of device removal] case narrative: consumer reported via phone that cotton is falling apart during removal.No serious injury reported.

• Brand Name: TAMPAXTAMPONSRADIANTRADIANTSUPERPLUSUNSCNT28CT
• 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: 22414464
• Report Number: 1219109-2025-00193
• Device Sequence Number: 8257201
• Product Code: HEB
• UDI-Device Identifier: 00073010631113
• UDI-Public: (01)00073010631113
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K110669
• 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): 07/11/2025

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: 5023243050 47 23:57
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• 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: 07/07/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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: 28 YR
• Patient Sex: Female