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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION - CONWAY MILL POISE PADS LONG LENGTH, MAXIMUM ABSORBENCY; GARMENT PROTECTIVE FOR INCONTINENCE
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KIMBERLY-CLARK CORPORATION - CONWAY MILL POISE PADS LONG LENGTH, MAXIMUM ABSORBENCY; GARMENT PROTECTIVE FOR INCONTINENCE Back to Search Results
Lot Number UPC 036000195705
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Irritation (1941); Pain (1994); Burning Sensation (2146)
Event Date 04/24/2016
Event Type  Injury  
Event Description
After using poise pads long length, maximum protection (upc (b)(4)), i developed intense burning and pain in my perineal area.I had severe pain when urinating and it felt like my labia were literally on fire.This is the 2nd pad that i have used and it happened with the 1st pad but i didn't think anything about the possibility of the pad causing the issue.With the 2nd pad, the intense burning and pain was beyond imaginable.I'm not sure what chemicals kimberly-clark uses to make the pads or what link is used for the purple decorations on the absorbent pad itself but it is very irritating.It literally feels like someone is holding a burning candle to my private parts.Please investigate these pads as they are very irritating and painful to wear.Fda safety report id# (b)(4).
 
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Brand Name
POISE PADS LONG LENGTH, MAXIMUM ABSORBENCY
Type of Device
GARMENT PROTECTIVE FOR INCONTINENCE
Manufacturer (Section D)
KIMBERLY-CLARK CORPORATION - CONWAY MILL
MDR Report Key8556688
MDR Text Key143452487
Report NumberMW5086224
Device Sequence Number1
Product Code EYQ
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 04/24/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot NumberUPC 036000195705
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age55 YR
Patient Weight75
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