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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 SUPER
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 07/22/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Records demonstrate that quality system procedures were correctly followed and the finished product met all quality release criteria and specifications were within allowable limits prior to release.
 
Event or Problem Description
Consumer reported via e-mail that multiple tampons were pulling apart very easily.Multiple attempts have been made to obtain further information regarding the consumer¿s use of the product and outcome, however, no further information has been received.
 
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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 Key12339418
Report Number3011109575-2021-00428
Device Sequence Number4055826
Product Code HEB
UDI-Device Identifier00036000515848
UDI-Public036000515848
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K172118
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/18/2021
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 NumberSUPER
Device Lot NumberNN029413B2120
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 07/22/2021
Initial Report FDA Received Date08/18/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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