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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/08/2021
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 found a piece of pledget inside her vaginal cavity after removing a tampon she had worn for two hours.She was able to manually remove the piece 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 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 Key12084510
Report Number2381757-2021-00083
Device Sequence Number11674529
Product Code HEB
UDI-Device Identifier00036000515695
UDI-Public036000515695
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
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) 06/29/2021
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 NumberAC003021X0404
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 06/03/2021
Initial Report FDA Received Date06/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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