BEUDAMED
    FDA Adverse Event Summary report: N

    CV MEDICATED LOTION SOAP

    MDR report key: 1891402 · Received November 4, 2010

    Report

    Report Number
    1937531-2010-00004
    Date Received
    November 4, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 4, 2010
    Manufacturer
    STERIS CORPORATION
    Product Code
    LRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CV MEDICATED LOTION SOAP LABELING STATES, "WARNING: FOR EXTERNAL USE ONLY," AND IS TO BE USED FOR WASHING THE HANDS ONLY. STERIS OFFERED TO CONDUCT IN-SERVICE TRAINING REGARDING THE PROPER USE OF THE CV MEDICATED LOTION SOAP HOWEVER THE DOCTOR DECLINED. STERIS WILL SUBMIT AN UPDATED REPORT SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT A DOCTOR USED CV MEDICATED LOTION SOAP INSTEAD OF LUBRICANT ON HER DURING A PELVIC EXAMINATION AFTER SURGERY HAD BEEN COMPLETED THE DAY PRIOR, CAUSING BURNING AND PAIN. HOSPITAL PERSONNEL FLUSHED THE AFFECTED AREA WITH WATER. THE PATIENT REPORTED THE BURNING DISSIPATED APPROXIMATELY TWO HOURS LATER. THE PATIENT REMAINS ON MEDICAL LEAVE AS A RESULT OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CV MEDICATED LOTION SOAP MEDICATED SOAP LRJ STERIS CORPORATION 4704512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other