BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-Y BRAND, UNSPECIFIED

    MDR report key: 1440395 · Received August 12, 2009

    Report

    Report Number
    2214133-2009-00009
    Event Type
    Injury
    Date Received
    August 12, 2009
    Date of Event
    July 19, 2009
    Report Date
    July 24, 2009
    Manufacturer
    MCNEIL-PPC, INC.
    Product Code
    NUC
    PMA / PMN Number
    UNK PROD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS CLOSED UNTIL OTHER SIGNIFICANT INFO IS RECEIVED.

    Description of Event or Problem · 1

    THE CONSUMER IS A FEMALE WITH A HISTORY OF ASTHMA AND ALLERGY TO MILK, AND WHOSE CONCOMITANT MEDICATIONS INCLUDE ALBUTEROL. SHE FIRST USED AN UNSPECIFIED KY PRODUCT IN 2009. SHE STATED THAT AFTER USE OF THIS PRODUCT ONE TIME SHE DEVELOPED BURNS WHICH CAUSED LACERATIONS AND BLISTERS ON THE EXTERNAL VAGINAL AREA. AT ABOUT 2 DAYS LATER, SHE VISITED A WALK IN CLINIC; SHE STATES THAT THE DIAGNOSIS OF "BURNS THAT CAUSED LACERATIONS, BLISTERS" WAS MADE, AND THAT SIX STITCHES WERE PLACED ON THE EXTERNAL VAGINAL AREA. SHE WAS TREATED WITH PAIN MEDICATION, ANTIBIOTIC BURN CREAM AND LIDOCAINE. AT THE TIME OF CONTACT AT ABOUT 3 DAYS LATER, SYMPTOMS HAD ABATED SLIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-Y BRAND, UNSPECIFIED PERSONAL LUBRICANT NUC MCNEIL-PPC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention ALBUTEROL FOR ASTHMA