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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/21/2021
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 upon removal a tampon unraveled and she was unsure if pieces remained inside her vaginal cavity.She was able to remove the tampon 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 Key12649667
Report Number3011109575-2021-00595
Device Sequence Number4299125
Product Code HEB
UDI-Device Identifier00036000515886
UDI-Public036000515886
Combination Product (Y/N)N
Initial Reporter StateMD
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) 10/18/2021
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 NumberREGULAR
Device Lot NumberNN034613D0055
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 09/22/2021
Initial Report FDA Received Date10/18/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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