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	REGULAR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858); Nausea (1970); Vomiting (2144); Foreign Body In Patient (2687)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Consumer reported she wore a tampon for 8 hours and upon removal on (b)(6) 2024, the string separated from the pledget.She attempted to remove the pledget and a piece of pledget broke off and remained inside of her.She was unable to remove the remaining piece and on the same day, (b)(6) 2024, she went to the emergency room for removal.The consumer reported experiencing a fever, abdominal pain, nausea, and vomiting.She reported that the emergency room provider felt that she had the start of tss, prescribed her amoxicillin and administered a dose of amoxicillin in the emergency room.She reports she was instructed to return to the emergency room if her symptoms worsened.As of her reporting on (b)(6) 2024, the consumer still had a fever and some abdominal cramping, but was unsure if it was related to her period.Multiple attempts have been made to obtain further information regarding the consumer¿s use of the product and outcome; however, no further information has been received.

• 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: 19228425
• Report Number: 3011109575-2024-00038
• Device Sequence Number: 5665164
• Product Code: HEB
• UDI-Device Identifier: 00036000515862
• UDI-Public: 00036000515862
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: REGULAR
• Device Lot Number: NN329113B0436
• 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: 04/05/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female