BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ LUBRICATING JELLY

    MDR report key: 6947967 · Received October 13, 2017

    Report

    Report Number
    6947967
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    July 3, 2017
    Report Date
    September 25, 2017
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    KMJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EZ LUBE IS SOLD AS A LUBRICANT USED READILY IN THE OUTPATIENT SETTING. AFTER YEARS OF USING THE PRODUCT, WE ARE MAKING THE FULL TRANSITION OVER TO SURGILUBE. IT WAS FOUND THAT A STUDY FROM 2014 IDENTIFIED BRANDS OF LUBRICANTS THAT WERE NOT COMPATIBLE WITH PAP SMEAR, THIN PREP. FURTHER INVESTIGATION IDENTIFIED THAT EZ LUBE MAY CAUSE THE CELLS TO CLUMP AND RESULT IN A HIGHER PERCENTAGE OF UNSATISFACTORY PAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727310 EZ LUBRICATING JELLY LUBRICANT, PATIENT, VAGINAL KMJ MEDLINE INDUSTRIES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR NO| NO OTHER THERAPIES