BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES SKYN

    MDR report key: 4736145 · Received April 17, 2015

    Report

    Report Number
    1019632-2015-00004
    Event Type
    Injury
    Date Received
    April 17, 2015
    Report Date
    April 17, 2015
    Manufacturer
    SURETEX LTD.
    Product Code
    MOL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ANSELL HEALTHCARE PRODUCTS LLC IS SUBMITTING THIS REPORT ON BEHALF OF SURETEX LTD. INCIDENT OCCURRED IN THE UK; HOWEVER, THE SKYN PRODUCT IS ALSO SOLD IN THE USA.

    Description of Event or Problem · 1

    THE CUSTOMERS BOYFRIEND INFORMED ANSELL (B)(6) THAT AFTER USING A LIFESTYLES POLYISOPRENE LUBRICATED CONDOM AN EPIC PEN WAS USED AND AN AMBULANCE CALLED THAT TOOK HER TO THE HOSP AND SHE WAS GIVEN A FURTHER DOSE OF MEDICATION TO CURE ANAPHYLACTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258888 LIFESTYLES SKYN LUBRICATED POLYISOPRENE CONDOM MOL SURETEX LTD. 1305033016

    Patients

    Seq Age Sex Outcome Treatment
    1 Other