• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KY BRAND MARQUE WARMING LIQUID; KY JELLY WARMING LIQUID

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KY BRAND MARQUE WARMING LIQUID; KY JELLY WARMING LIQUID Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2015
Event Type  Injury  
Event Description
I, along with my boyfriend, went away for a weekend.I used ky jelly warming liquid.Well, that was the beginning of one of the worst weeks in my life and also the wrecking of the weekend.First, i called and the person i had to speak with was rude, disinterested, and said there was nothing that she could do.I asked to speak with the manger in charge, she said she was that person.I contacted attorney (b)(6) to represent me and he spoke with (b)(6); ref: (b)(4).I have tried to contact (b)(6) myself but to no avail.I've subsequently texted and called attorney (b)(6) and he hasn't responded, which leaves me to assume he doesn't have any updates.All info has been forwarded via attorney to ky (as per attorney).Reason for use: dryness.Is the product over the counter: yes; event abated after use, stopped or dose reduced: no.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
KY BRAND MARQUE WARMING LIQUID
Type of Device
KY JELLY WARMING LIQUID
MDR Report Key5553767
MDR Text Key42170770
Report NumberMW5061520
Device Sequence Number1
Product Code KMJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/01/2016
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 Received04/01/2016
Type of Device Usage N
Patient Sequence Number1
Patient Age60 YR
Patient Weight104
-
-