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	Material Separation (1562)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Records demonstrate that the finished product was produced according to specifications, met all quality acceptance criteria for product release, and quality system procedures were correctly followed.A medical assessment conducted by a healthcare professional deemed the information documented in b7 to be not clearly attributable to the alleged product problem.A follow up report will be submitted if additional relevant information is obtained.
Event or Problem Description
Consumer reported that upon removal of a tampon, the string separated in one piece.She manually removed the pledget from her vaginal cavity while wearing gloves.Consumer reported the tampon had been in use for a total of 1 hour.She experienced vaginal pain from her gloved fingers following manual removal of the pledget.No treatment was required.She stated that after this event, she checked other tampons in the package and observed the string detached in varying ways, separating in one piece in some instances and separating into multiple pieces in others.These tampons were not used.Additional information has been requested but not yet received.

• 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: 22529657
• Report Number: 3011109575-2025-00033
• Device Sequence Number: 7932554
• Product Code: HEB
• UDI-Device Identifier: 00036000515824
• UDI-Public: (01)00036000515824(10)NN302913C
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

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: NN302913C1740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2023
• 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