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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported prior to insertion of a tampon that the string was present.Upon attempted removal of the tampon, she alleged that the string was missing.She reported that she and her husband were unsuccessful in attempting to remove the tampon.She went to the emergency room to have the tampon removed from her vaginal cavity.It was reported that the doctor confirmed the string was missing at that time.The consumer was prescribed an unknown oral antibiotic as a precaution.She did not experience any adverse health effects.
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.H3 other text : not returned to manufacture.

• Brand Name: U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
• Common Device Name: 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: 19052289
• Report Number: 3011109575-2024-00030
• Device Sequence Number: 15208723
• Product Code: HEB
• UDI-Device Identifier: 00036000515817
• UDI-Public: 00036000515817
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K223749
• 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): 04/05/2024

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
• Device Lot Number: NN325214C0928
• 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: 03/12/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2023
• 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: 37 YR
• Patient Sex: Female