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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
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2016
Event Type  malfunction  
Manufacturer Narrative
Device history record could not be reviewed as lot code was not provided by the consumer.Information from this incident will be included in our product complaint and mdr trend analysis.Consumer had not returned unused product for evaluation at the time of this report.
 
Event Description
The consumer stated that her tampon came apart upon removal and she was unsure if pieces remained inside of her.
 
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Brand Name
U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB
Type of Device
TAMPON, MENSTRUAL, UNSCENTED
Manufacturer (Section D)
KIMBERLY-CLARK CORPORATION - CONWAY MILL
480 exchange ave.
conway AR 72032 7191
Manufacturer Contact
angie masaro
2100 winchester rd.
neenah, WI 54956
9207215934
MDR Report Key5570616
MDR Text Key43050313
Report Number2381757-2016-00014
Device Sequence Number1
Product Code HEB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK141294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSUPER
Was Device Available for Evaluation? No
Date Manufacturer Received03/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age47 YR
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