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	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
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 the string was not available for removal therefore she had to manually remove the pledget from her vaginal cavity.She alleged the string was stuck to the pledget.She was able to remove the pledget in one piece and did not seek medical attention.She did not experience any adverse health effects.
Additional Manufacturer Narrative
New information: b5: companion samples were received for evaluation.No product defects or abnormalities were observed.D10: device available for evaluation and returned to manufacturer.G7: follow-up 1.H2: follow-up type.H3: device evaluated by manufacturer.
Event or Problem Description
Companion samples were received for evaluation.No product defects or abnormalities were observed.

• 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: 10556744
• Report Number: 3011109575-2020-01738
• Device Sequence Number: 2670498
• Product Code: HEB
• UDI-Device Identifier: 00036000490305
• UDI-Public: 036000490305
• 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): 10/28/2020

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: SUPER
• Device Lot Number: NN006014C1606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR