MAUDE Adverse Event Report: K-C AFC MANUFACTURING, S. DE R.L. DE C.V U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB

Model Number	KOTEX TAMPONS
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in process.A supplemental/final follow-up report will be submitted upon completion.
Event or Problem Description
Report 1 of 2.Non-us event; occurred in canada.Consumer reported via email that prior to use of an unspecified number of regular absorbency tampons, the insertion tube was open at the top which hurt if she used it.She did not report any serious adverse health effects or the need for medical attention.
Additional Manufacturer Narrative
The consumer provided sample photos and the tampon opening at the tip was unable to be determined if wider than the acceptable limit.No physical samples were provided.Records show this lot was produced according to the specification and met the acceptance criteria for product release.This lot confirmed no open petals were observed during the production of this lot.New information: g3: date received.G6: type of defect.H1: type of reported event.H2: if follow-up, what type.H6: investigation findings and investigation conclusion.H11: additional narrative.

• Brand Name: U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
• Common Device Name: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): K-C AFC MANUFACTURING, S. DE R.L. DE C.V; calzada industrial de las maquiladoras #87; nuevo nogales; nogales, sonora mexico 84094 ; MX 84094
• Manufacturer (Section G): K-C AFC MANUFACTURING, S. DE R.L. DE C.V; calzada industrial de las maquiladoras #87; nuevo nogales; nogales, sonora mexico 84094 ; MX 84094
• Manufacturer Contact: emily arnould, rn bsn ; 2100 winchester rd; neenah, WI 54956 ; 9207213128
• MDR Report Key: 23356487
• Report Number: 3011109575-2025-00070
• Device Sequence Number: 15671418
• Product Code: HEB
• UDI-Device Identifier: 00036000515831
• UDI-Public: (01)00036000515831(10)NN422213C
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K223749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: KOTEX TAMPONS
• Device Lot Number: NN422213C
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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 Sex: Female