MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT96CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	43262430154613:58
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); High Blood Pressure/ Hypertension (1908); Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.
Event or Problem Description
Tampon/retained in vagina [foreign body in reproductive tract].High blood pressure-do to incident body [hypertension].Headache due to blood pressure head [headache].The entire rope came undone- tampax pearl [device breakage].Tried to remove it.Had to go to the er [complication of device removal].Case narrative: consumer reported via phone that the tampon rope came undone.No serious injury was reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.
Event or Problem Description
Tampon/retained in vagina [foreign body in reproductive tract] high blood pressure-do to incident body [hypertension] headache due to blood pressure head [headache] the entire rope came undone- tampax pearl [device breakage] tried to remove it.Had to go to the er [complication of device removal] case narrative: consumer reported via phone that the tampon rope came undone.No serious injury was reported.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT96CT
• 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: 21970310
• Report Number: 1219109-2025-00128
• Device Sequence Number: 20898109
• Product Code: HEB
• UDI-Device Identifier: 00073010013711
• UDI-Public: (01)00073010013711
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 43262430154613:58
• Was Device Available for Evaluation?: No
• 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
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/27/2025
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 59 KG