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	REGULAR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
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
Consumer reported she wore a tampon for eight hours and upon removal the tampon fell apart leaving pieces inside her vaginal cavity.She went to her doctor and her doctor performed a vaginal exam.During the vaginal exam, the doctor remove more pieces of pledget from her vaginal cavity.She did not receive any additional medical treatment and did not experience any adverse health effects.

• 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: 10900126
• Report Number: 3011109575-2020-01807
• Device Sequence Number: 1429953
• Product Code: HEB
• UDI-Device Identifier: 00036000426649
• UDI-Public: 036000426649
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K112635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: REGULAR
• Device Lot Number: NN915413A1416
• 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: 11/05/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR