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 Abdominal Pain (1685); Pain (1994); Abnormal Vaginal Discharge (2123)

Event Date 03/20/2021

Event Type  malfunction  

Manufacturer Narrative

Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the malfunction.

Event Description

Consumer reported upon inserting a tampon the plastic applicator broke leaving pieces inside her vaginal cavity.She subsequently experienced pain and abnormal vaginal discharge.She stated she had sharp pains in the right and left side of her lower abdomen and an abnormal amount of discharge and pain when urinating.Her symptoms worsened so she sought medical attention.The doctor did not perform a vaginal exam but prescribed unspecified antibiotics.She had a friend remove some of the applicator from her vaginal cavity.She reported her symptoms have improved.

• 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: 11738526
• MDR Text Key: 249982521
• Report Number: 3011109575-2021-00115
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00036000998405
• UDI-Public: 00036000998405
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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: AA406801B0328
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2014
• 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: 20 YR