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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION - CONWAY MILL U BY KOTEX SLEEK; TAMPON
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KIMBERLY-CLARK CORPORATION - CONWAY MILL U BY KOTEX SLEEK; TAMPON Back to Search Results
Model Number REGULAR
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2014
Event Type  malfunction  
Event Description
This is a non-us event.The event occurred in (b)(6).The consumer stated that her tampon came apart upon removal and tampon pieces remained inside of her.She was able to remove the remaining pieces.
 
Manufacturer Narrative
Device history record is under review.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.
 
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Brand Name
U BY KOTEX SLEEK
Type of Device
TAMPON
Manufacturer (Section D)
KIMBERLY-CLARK CORPORATION - CONWAY MILL
480 exchange ave.
conway AR 72032 719
Manufacturer Contact
charnelle thomas
1400 holcomb bridge rd.
roswell, GA 30076
6783526031
MDR Report Key3637140
MDR Text Key3983816
Report Number2381757-2014-00009
Device Sequence Number1
Product Code HEB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K112635
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberREGULAR
Device Lot NumberAC317366X1427
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2013
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 Age40 YR
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