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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KIMBERLY-CLARK CORP., CONWAY MILL U KOTEX SLEEK; TAMPONS, MENSTRUAL, UNSCENTED
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KIMBERLY-CLARK CORP., CONWAY MILL U KOTEX SLEEK; TAMPONS, MENSTRUAL, UNSCENTED Back to Search Results
Lot Number NN722013B
Device Problems Entrapment of Device (1212); Material Fragmentation (1261)
Patient Problems Unspecified Infection (1930); Pain (1994); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165)
Event Date 04/30/2018
Event Type  Injury  
Event Description
From (b)(6) 2018 - present day i have had several vaginal infections, pain and excess bleeding.I have been to the hospital for the infections but not knowing about the tampons, it was passed off as a kidney or bladder infection.I noticed recently things coming out of me when i was on my period, but once again i didn't know about the tampon recall, and thought it was just large blood clots.I will be going to the hospital in the morning to make sure everything is out of me now that i know it¿s pieces of tampon¿s inside of me.Frequency: as needed; how was it taken or used: vaginal; date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018; why was the person using the product? pms.
 
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Brand Name
U KOTEX SLEEK
Type of Device
TAMPONS, MENSTRUAL, UNSCENTED
Manufacturer (Section D)
KIMBERLY-CLARK CORP., CONWAY MILL
MDR Report Key8180908
MDR Text Key131306584
Report NumberMW5082298
Device Sequence Number1
Product Code HEB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Lot NumberNN722013B
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age28 YR
Patient Weight61
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