BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KY WARMING LIQUID

    MDR report key: 1515947 · Received October 23, 2009

    Report

    Report Number
    2214133-2009-00010
    Event Type
    Injury
    Date Received
    October 23, 2009
    Date of Event
    September 22, 2009
    Report Date
    September 25, 2009
    Manufacturer
    MCNEIL-PPC, INC
    Product Code
    NUC
    PMA / PMN Number
    UNK PROD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CLOSES OUT THIS REPORT UNLESS ADD'L SIGNIFICANT INFO IS REC'D. REPORT SENT TO FDA ON 10/23/2009.

    Description of Event or Problem · 1

    PT STATES THAT SHE EXPERIENCED AN INCREASE IN VAGINAL BURNING ABOUT 1/2 HOUR AFTER INTERCOURSE, WENT TO ER, DIAGNOSED AND TREATED FOR 2ND DEGREE VAGINAL BURNS AND BLISTER. WAS GIVEN AN UNSPECIFIED CREAM TO APPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KY WARMING LIQUID PERSONAL LUBRICANT NUC MCNEIL-PPC, INC NA 0236C

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention