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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 REGULAR
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/03/2020
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 she wore a tampon for six hours and upon removal the pledget fell apart leaving a piece inside her vaginal cavity.She believed the piece of pledget came out of her body on its own.She did not experience any adverse health effects and did not seek medical attention.
 
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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 Key10677290
Report Number2381757-2020-00471
Device Sequence Number11540739
Product Code HEB
UDI-Device Identifier00036000515695
UDI-Public036000515695
Combination Product (Y/N)N
Initial Reporter StateNY
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) 10/14/2020
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
Device Lot NumberAC006821X0843
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 10/03/2020
Initial Report FDA Received Date10/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age25 YR
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