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

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

This is a non-us event.This occurred in (b)(6).Consumer reported via e-mail that upon removal of a tampon, the pledget fell apart into two pieces.She manually removed the remaining piece from her vaginal cavity.She reported that she will be making an appointment with her doctor to ensure no pieces remain.Multiple attempts have been made to obtain further information regarding the consumer¿s outcome; however, no further information has been received.

Manufacturer Narrative

A model, udi or manufacturer lot code were not provided.With no means to determine 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.

• Brand Name: U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
• Type of Device: 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: 17863042
• MDR Text Key: 324831081
• Report Number: 3011109575-2023-00216
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female