MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZEREG+SUPERUNSCNT48CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	5082243028 10 00:48
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); 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
Liner/casing around the tampon itself is separating from the tampon.This thin liner sticks inside and has to be torn away from the body [foreign body in reproductive tract].Uncomfortable- vaginal [vulvovaginal discomfort].Discomfort- inside around the tampon [medical device site discomfort].Painful- vaginal [vulvovaginal pain].Pain - inside around the tampon [medical device site pain].Liner/casing around the tampon itself is separating from the tampon [device breakage].The removal is very painful [complication of device removal].Case narrative: consumer reported via e-mail that the liner/casing around the tampon is separating from the tampon itself.No serious injury reported.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZEREG+SUPERUNSCNT48CT
• 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: 22213287
• Report Number: 1219109-2025-00173
• Device Sequence Number: 8620365
• Product Code: HEB
• UDI-Device Identifier: 00073010719972
• UDI-Public: (01)00073010719972
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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): 06/16/2025

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: 5082243028 10 00:48
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2025
• 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: 38 YR
• Patient Sex: Female