MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZEMIXEDUNSCNT34CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	4325243008 96 03:36
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
Had to dig pieces out in chunks- vagina [foreign body in reproductive tract].Fell apart inside of me- tampon [device breakage].Went to pull one out after an hour, fell apart inside of me [complication of device removal].Case narrative: consumer reported via email that the tampon fell apart inside of her.No serious injury was 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
Had to dig pieces out in chunks- vagina [foreign body in reproductive tract] fell apart inside of me- tampon [device breakage] went to pull one out after an hour.Fell apart inside of me [complication of device removal] case narrative: consumer reported via email that the tampon fell apart inside of her.No serious injury was reported.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZEMIXEDUNSCNT34CT
• 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: 21400545
• Report Number: 1219109-2025-00043
• Device Sequence Number: 9345298
• Product Code: HEB
• UDI-Device Identifier: 00073010711396
• UDI-Public: (01)00073010711396
• 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): 03/24/2025

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: 4325243008 96 03:36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/31/2025
• 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