MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION - CONWAY MILL U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB

Model Number	SUPER PLUS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Consumer reported upon removal a tampon fell apart leaving half of the pledget inside her vaginal cavity.She manually removed the remaining pledget piece and did not seek medical attention.She did not report any adverse health effects.

• Brand Name: U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB
• Common Device Name: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION - CONWAY MILL; 480 exchange ave.; conway AR 72032 7191
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION - CONWAY MILL; 480 exchange ave.; conway AR 72032 7191
• Manufacturer Contact: emily arnould, rn bsn ; 2100 winchester rd; neenah, WI 54956 ; 9207213128
• MDR Report Key: 15159566
• Report Number: 2381757-2022-00003
• Device Sequence Number: 17611019
• Product Code: HEB
• UDI-Device Identifier: 00036000515718
• UDI-Public: 036000515718
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141294
• 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): 08/03/2022

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: SUPER PLUS
• Device Lot Number: AC010327X0057
• 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: 07/11/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2020
• 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 Age: 49 YR
• Patient Sex: Female