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 Codes	Material Separation (1562); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2020
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
This is a non-us event.This occurred in (b)(6).Consumer reported she wore a tampon for approximately three hours and upon removal the string pulled out leaving the pledget inside her vaginal cavity.She was able to manually remove the tampon pledget with assistance from her husband who is a medic.Upon removal the pledget fell apart into pieces.She was confident no pledget pieces remained inside her vaginal cavity and she did not seek medical attention.She did not experience any adverse health effects.
Additional Manufacturer Narrative
Device evaluation: the consumer returned unused samples from what is believed to be the same lot number provided in (b)(4).A visual inspection was conducted and no string separation or pledget falls apart defects were noted with the product returned; however, there was one tampon with the string cut short, potentially due to manufacturing.Upon review of the device history record (dhr), the lot met all acceptance criteria at the time of release.

• 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
• MDR Report Key: 10556653
• Report Number: 3011109575-2020-01736
• Device Sequence Number: 16811899
• Product Code: HEB
• UDI-Device Identifier: 00036000515909
• UDI-Public: 036000515909
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: NN002613D0410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR