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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K-Y WARMING SENSATION

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K-Y WARMING SENSATION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burning Sensation (2146); Patient Problem/Medical Problem (2688)
Event Date 04/28/2016
Event Type  Injury  
Event Description
I used ky warming lube and had this really bad burning occur.A few days after i used it i noticed i couldn't walk and i had bumps inside and around my vulva, like how they would describe herpes to be.
 
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Brand Name
K-Y WARMING SENSATION
Type of Device
K-Y WARMING SENSATION
MDR Report Key5633767
MDR Text Key44562945
Report NumberMW5062098
Device Sequence Number1
Product Code KMJ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/02/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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