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	REGULAR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.H3 other text: not returned to manufacture.
Event or Problem Description
Consumer reported upon insertion and removal of an unspecified number of tampon applicators, she noticed pledget pieces on the applicator.After removal of the unspecified number of tampons from her vaginal cavity and after wiping with toilet paper, she noticed pledget pieces on the toilet paper.She reported feeling confident that no pieces of pledget remained in her vaginal cavity.Multiple attempts have been made to check on the consumer's current status; however, no further information has been 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: 17129674
• Report Number: 3011109575-2023-00158
• Device Sequence Number: 7322949
• Product Code: HEB
• UDI-Device Identifier: 00036000534450
• UDI-Public: 036000534450
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/14/2023

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: REGULAR
• 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: 05/22/2023
• Initial Report FDA Received Date: 06/14/2023
• 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 Sex: Female