BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGILUBE

    MDR report key: 3359488 · Received February 9, 2007

    Report

    Report Number
    2432435-2006-00001
    Event Type
    Injury
    Date Received
    February 9, 2007
    Date of Event
    September 5, 2006
    Report Date
    November 20, 2006
    Manufacturer
    ALTANA INC.
    Product Code
    KMJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED BURNING SENSATION IN VAGINAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGILUBE SURGILUBE LUBRICANT KMJ ALTANA INC. 0168-0205-43 T324

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other