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 04/03/2023

Event Type  malfunction  

Event Description

Report 1 of 2.Consumer reported via social media that upon removal of a tampon, the string detached and the pledget fell apart.An attempt has been made to obtain further information regarding the consumer¿s use of the product and 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.

• 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: 16762761
• MDR Text Key: 313516188
• Report Number: 3011109575-2023-00111
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/18/2023
• 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