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	Difficult to Remove (1528)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/11/2021
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 the string was caught up in the insertion tube but she inserted the tampon anyway and upon removal was unable to find the string.After wearing the tampon 30 minutes she was uncomfortable due to the tampon being inserted too low.Upon removal she could not find the string and had to manually remove the pledget.The string was attached to the pledget but had been inside her along with the pledget.She stated she felt like her vaginal wall expanded as she removed the pledget.The discomfort resolved and she did not seek medical attention.She did not experience 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
• MDR Report Key: 12456135
• Report Number: 2381757-2021-00092
• Device Sequence Number: 11779106
• Product Code: HEB
• UDI-Device Identifier: 00036000515756
• UDI-Public: 036000515756
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/10/2021

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: AC015622X0220
• 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: 08/11/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR