BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES SILKY SMOOTH PERSONAL LUBRICANT

    MDR report key: 6447390 · Received March 30, 2017

    Report

    Report Number
    1019632-2017-00006
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    February 22, 2017
    Report Date
    July 20, 2017
    Manufacturer
    IDS MANUFACTURING CO,.LTD
    Product Code
    NUC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2017 - TESTED FACTORY RETAIN SAMPLES, CHECKED DHR/PRODUCTION RECORDS AND ALSO TESTED THE RETURNED SAMPLE (UNUSED FROM STOCK). ALL TEST RESULTS SHOWED NO ABNORMALITY AND ALL WERE WITHIN PRODUCT RELEASE SPECIFICATIONS. LUBRICANT ALSO CONTAINS NO BANANA OR ORANGE EXTRACT. NO ROOT CAUSE WAS IDENTIFIABLE AND COULD BE DUE TO USER'S EXISTING SENSITIVITIES. NO FURTHER ACTION CAN BE TAKEN AT THIS TIME. THE REPORTING OF THIS EVENT WAS DUE TO A US EQUIVALENT PRODUCT AVAILABLE IN THE US (LIFESTYLES 2 IN 1 PERSONAL LUBRICANT). NO SIMILAR EVENTS HAVE BEEN REPORTED TO DATE IN THE US MARKET FOR THIS PRODUCT . (B)(6) 2017 FACTORY RETAIN SAMPLES TESTED, DHR/PRODUCTION RECORDS CHECK, AND TESTING OF RETURNED SAMPLES. ALL RESULTS AND REPORTS SHOWED NO ABNORMALITY AND PRODUCT WAS MANUFACTURED IN SPECIFICATION WITHOUT DEVIATION. NO IDENTIFIABLE ROOT CAUSE COULD BE DONE WITH RESPECT TO THE INCIDENT. NO FURTHER INVESTIGATION CAN BE MADE AND THE EVENT IS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 - TESTED FACTORY RETAIN SAMPLES, CHECKED DHR/PRODUCTION RECORDS AND ALSO TESTED THE RETURNED SAMPLE (UNUSED FROM STOCK). ALL TEST RESULTS SHOWED NO ABNORMALITY AND ALL WERE WITHIN PRODUCT RELEASE SPECIFICATIONS. LUBRICANT ALSO CONTAINS NO BANANA OR ORANGE EXTRACT. NO ROOT CAUSE WAS IDENTIFIABLE AND COULD BE DUE TO USER'S EXISTING SENSITIVITIES. NO FURTHER ACTION CAN BE TAKEN AT THIS TIME. THE REPORTING OF THIS EVENT WAS DUE TO A US EQUIVALENT PRODUCT AVAILABLE IN THE US (LIFESTYLES 2 IN 1 PERSONAL LUBRICANT). NO SIMILAR EVENTS HAVE BEEN REPORTED TO DATE IN THE US MARKET FOR THIS PRODUCT .

    Description of Event or Problem · 1

    (B)(6) 2017 INCIDENT OCCURED IN (B)(6) WITH AN (B)(6) PRODUCT VARIANT. CUSTOMER STATES THAT PARTNER HAS HAD TWO INCIDENTS OF REACTION AFTER USING ANSELL LIFESTYLES SILKY SMOOTH LUBRICANT. THE FIRST REACTION WAS "STINGING PAIN" THAT WENT AWAY AFTER A COUPLE OF DAYS. THE SECOND REACTION CAUSED VERY INTENSE STINGING PAIN REQUIRING THE PARTNER TO GO TO THE HOSPITAL FOR TREATMENT. SHE WAS TREATED FOR AN ALLERGIC REACTION (MEDICATION PRESCRIBED UNKNOWN) AND SHE WAS RELEASED AFTER 5-6 HOURS.

    Description of Event or Problem · 1

    ON (B)(6) 2017 INCIDENT OCCURED IN (B)(6) WITH AN (B)(4) PRODUCT VARIANT. CUSTOMER STATES THAT PARTNER HAS HAD TWO INCIDENTS OF REACTION AFTER USING ANSELL LIFESTYLES SILKY SMOOTH LUBRICANT. THE FIRST REACTION WAS "STINGING PAIN" THAT WENT AWAY AFTER A COUPLE OF DAYS. THE SECOND REACTION CAUSED VERY INTENSE STINGING PAIN REQUIRING THE PARTNER TO GO TO THE HOSPITAL FOR TREATMENT. SHE WAS TREATED FOR AN ALLERGIC REACTION (MEDICATION PRESCRIBED UNKNOWN) AND SHE WAS RELEASED AFTER 5-6 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228976 LIFESTYLES SILKY SMOOTH PERSONAL LUBRICANT PERSONAL LUBRICANT NUC IDS MANUFACTURING CO,.LTD 16100104DR

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention