MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZEULTRAUNSCNT32CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	5130243002630658
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abnormal Vaginal Discharge (2123); Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product investigation is in progress.
Event or Problem Description
Pieces of it (tampon) must have come apart inside me- vagina [foreign body in reproductive tract].Rotten egg odor vagina [vaginal odour].Pieces of it must have come apart inside me- tampax pearl [device breakage].Case narrative: consumer reported via phone that the tampon pieces must have come apart inside of her.No serious injury was reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.
Event or Problem Description
Pieces of it (tampon) must have come apart inside me- vagina [foreign body in reproductive tract].Rotten egg odor vagina [vaginal odour].Pieces of it must have come apart inside me- tampax pearl [device breakage].Case narrative: consumer reported via phone that the tampon pieces must have come apart inside of her.No serious injury was reported.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZEULTRAUNSCNT32CT
• 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: 22496780
• Report Number: 1219109-2025-00199
• Device Sequence Number: 15197378
• Product Code: HEB
• UDI-Device Identifier: 00073010714533
• UDI-Public: (01)00073010714533
• 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): 07/22/2025

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: 5130243002630658
• 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: 07/14/2025
• Supplement Report FDA Received Date: 08/11/2025
• 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 Age: 38 YR
• Patient Sex: Female