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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
Infection - vaginal [vaginal infection].Left pieces of the cotton and string inside me; emergency room found 2 more long pieces way up inside vagina [foreign body in reproductive tract].Fallen apart - tampax [device breakage].I'm removing the tampon.It had fallen apart inside my vagina and left pieces of cotton and string inside [complication of device removal].Case narrative: consumer reported via e-mail that the tampon has fallen apart inside her.No serious injury reported.
Additional Manufacturer Narrative
There is insufficient information to perform an investigation.

• 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: 24340378
• Report Number: 1219109-2026-00024
• Device Sequence Number: 9790781
• 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
• Report Date (Section B): 02/11/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2026
• 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: 37 YR
• Patient Sex: Female