MAUDE Adverse Event Report: K-C AFC MANUFACTURING, S. DE R.L. DE C.V U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB

Model Number	SUPER
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Abdominal Pain (1685); Headache (1880); Abdominal Cramps (2543)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
This is a non-us event.This occurred in (b)(6).Consumer reported she wore a tampon for two hours and upon removal the pledget fell apart leaving pieces inside her vaginal cavity.After this occurred she was finding pieces of pledget when wiping and experienced severe lower abdominal pain and cramping.She went to her doctor a few days later where the remaining pieces of pledget were removed from her vaginal cavity.Consumer experienced a lingering headache and abdominal cramping.She was prescribed naproxen for the pain.She was instructed to call her doctor for an antibiotic if her headache and cramping continued.Multiple attempts have been made to obtain further information regarding the consumer¿s outcome and any additional medical treatment, however, no further information has been received.

• Brand Name: U BY KOTEX SLEEK : 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
• MDR Report Key: 11598933
• Report Number: 3011109575-2021-00094
• Device Sequence Number: 3449651
• Product Code: HEB
• UDI-Device Identifier: 00036000426656
• UDI-Public: 036000426656
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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
• Device Lot Number: NN701713B0228
• 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: 03/03/2021
• Initial Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR