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 SUPER

Device Problem Material Fragmentation (1261)

Patient Problems Pain (1994); Discomfort (2330); Foreign Body In Patient (2687)

Event Date 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

Records demonstrate that quality system procedures were correctly followed and the finished product met all quality release criteria and specifications were within allowable limits prior to release.

Event Description

Consumer reported that pieces of the insertion tube had broken off and were left behind inside her vaginal cavity after inserting a tampon.She reported she felt a pinch upon inserting the tampon and while removing the insertion tube she felt a sharp pain.After insertion she noticed the top of the insertion tube looked broken and the petals were missing.She then felt sharp pieces of the insertion tube inside her vaginal cavity.She was unable to remove the insertion tube pieces on her own.She experienced continued discomfort and went to the er the next day.The er doctor removed four of five pieces of insertion tube.She was prescribed naproxen for her discomfort.She did not receive any additional medical treatment and her symptoms were improving.

• 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: 13549653
• MDR Text Key: 287708915
• Report Number: 3011109575-2022-00060
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00036000515879
• UDI-Public: 036000515879
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SUPER
• Device Lot Number: NN122213B0337
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• 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 Age: 35 YR
• Patient Sex: Female