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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION - CONWAY MILL U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB
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KIMBERLY-CLARK CORPORATION - CONWAY MILL U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB Back to Search Results
Model Number SUPER
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/20/2020
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
Consumer reported the string pulled out of an unspecified amount of tampons leaving the pledget inside her vaginal cavity.She had to manually remove the pledget.She did not seek medical attention and did not experience any adverse health effects.
 
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Brand Name
U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB
Common Device Name
TAMPON, MENSTRUAL, UNSCENTED
Manufacturer (Section D)
KIMBERLY-CLARK CORPORATION - CONWAY MILL
480 exchange ave.
conway AR 72032 7191
MDR Report Key10993050
Report Number2381757-2020-00497
Device Sequence Number19702501
Product Code HEB
UDI-Device Identifier00036000423389
UDI-Public036000423389
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K141294
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/11/2020
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 NumberSUPER
Device Lot NumberAC920324X1513
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2020
Initial Report FDA Received Date12/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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