MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT36CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	4328243042 63 18:52
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
The string broke off, causing the tampon to become stuck in my vagina [foreign body in reproductive tract].String broke off- tampon [device breakage].I pulled the string to remove a tampon, and the string broke off, causing the tampon to become stuck in my vagina [complication of device removal].Case narrative: consumer reported via e-mail that the string broke off during removal.No serious injury reported.
Event or Problem Description
The string broke off, causing the tampon to become stuck in my vagina [foreign body in reproductive tract].String broke off - tampon [device breakage].I pulled the string to remove a tampon, and the string broke off, causing the tampon to become stuck in my vagina [complication of device removal].Case narrative: consumer reported via e-mail that the string broke off during removal.No serious injury reported.
Additional Manufacturer Narrative
Product investigation is in progress.
Event or Problem Description
The string broke off, causing the tampon to become stuck in my vagina [foreign body in reproductive tract].String broke off- tampon [device breakage].I pulled the string to remove a tampon, and the string broke off, causing the tampon to become stuck in my vagina [complication of device removal].Case narrative: consumer reported via e-mail that the string broke off during removal.No serious injury reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.
Event or Problem Description
The string broke off, causing the tampon to become stuck in my vagina [foreign body in reproductive tract].String broke off, tampon [device breakage].I pulled the string to remove a tampon, and the string broke off, causing the tampon to become stuck in my vagina [complication of device removal].Case narrative: consumer reported via e-mail that the string broke off during removal.No serious injury reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT36CT
• 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: 22414475
• Report Number: 1219109-2025-00200
• Device Sequence Number: 8257207
• Product Code: HEB
• UDI-Device Identifier: 00073010012172
• UDI-Public: (01)00073010012172
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/10/2025

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: 4328243042 63 18:52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/05/2025; 09/23/2025; 12/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALWAYS THIN LINERS. ; IBUPROFEN. ; TAMPAX PEARL REGULAR.
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 82 KG