BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM JO

    MDR report key: 6309501 · Received February 7, 2017

    Report

    Report Number
    1032263-2017-00003
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    April 23, 2016
    Report Date
    February 7, 2017
    Manufacturer
    UNITED CONSORTIUM
    Product Code
    NUC
    PMA / PMN Number
    K150480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMMEDIATE BURNING SENSATION. SHE HAS EXPERIENCED THIS BEFORE FROM OTHER PRODUCTS. KY JELLY WAS A PAST BRAND THAT CAUSED THIS ISSUE, ALONG WITH ID WATER-BASED (NATURAL FEEL). DISCOMFORT LASTED UNTIL THE BODY WAS WASHED. ONCE PRODUCT WAS WASHED AWAY IRRITATION WAS GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91586 SYSTEM JO PERSONAL LUBRICANT NUC UNITED CONSORTIUM 40036 006126

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention