MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT18CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	4249243066680311
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
Event or Problem Description
Cotton is coming apart inside of me- vagina [foreign body in reproductive tract].Cotton is coming apart [device breakage].When i go to change my tampon, the cotton is coming apart inside of me [complication of device removal].Case narrative: consumer reported via e-mail that the cotton is coming apart inside.No serious injury reported.
Additional Manufacturer Narrative
Product investigation is in progress.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.
Event or Problem Description
Cotton is coming apart inside of me- vagina [foreign body in reproductive tract], cotton is coming apart [device breakage] , when i go to change my tampon, the cotton is coming apart inside of me [complication of device removal].Case narrative: consumer reported via e-mail that the cotton is coming apart inside.No serious injury reported.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT18CT
• 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: 21111499
• Report Number: 1219109-2025-00008
• Device Sequence Number: 12628408
• Product Code: HEB
• UDI-Device Identifier: 00073010479050
• UDI-Public: (01)00073010479050
• 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): 01/29/2025

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: 4249243066680311
• Was Device Available for Evaluation?: No
• 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: 01/09/2025
• Supplement Report FDA Received Date: 01/30/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female