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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K-C AFC MANUFACTURING, S. DE R.L. DE C.V U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
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K-C AFC MANUFACTURING, S. DE R.L. DE C.V U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB Back to Search Results
Model Number REGULAR
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/03/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A valid manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line, and day of production, no further investigation on documents, and supporting records can be performed.
 
Event or Problem Description
This is a non-us event.This occurred in (b)(6).Consumer reported she wore a tampon for four hours and upon removal the tampon fell apart leaving pieces inside her vaginal cavity.She manually removed the pieces of pledget, and did not seek medical attention.She did not experience any adverse health effects.
 
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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 Key10870153
Report Number3011109575-2020-01805
Device Sequence Number2895886
Product Code HEB
UDI-Device Identifier00036000515800
UDI-Public036000515800
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K172118
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,foreign
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/19/2020
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 NumberREGULAR
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 11/03/2020
Initial Report FDA Received Date11/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age21 YR
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