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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
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KIMBERLY-CLARK CORPORATION U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem Swelling (2091)
Event Date 12/01/2018
Event Type  malfunction  
Manufacturer Narrative
A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.
 
Event Description
Consumer reported she found a plastic piece of tampon applicator inside her.She experienced swelling of the vaginal canal.She reported the swelling has resolved.
 
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Brand Name
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
Type of Device
TAMPON, MENSTRUAL, UNSCENTED
Manufacturer (Section D)
KIMBERLY-CLARK CORPORATION
2100 winchester rd.
neenah WI 54956
Manufacturer (Section G)
KIMBERLY-CLARK CORPORATION
2100 winchester rd.
neenah WI 54956
Manufacturer Contact
emily arnould, rn bsn
2100 winchester rd
neenah, WI 54956
9207213128
MDR Report Key9466743
MDR Text Key170747558
Report Number3003701733-2019-00830
Device Sequence Number1
Product Code HEB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172118
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/26/2018
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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