BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLES ULTRA SENSITIVE

    MDR report key: 3004173 · Received March 12, 2013

    Report

    Report Number
    1019632-2013-00011
    Event Type
    Other
    Date Received
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    UNK
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    END USER ADVISED ANSELL HEALTHCARE LLC THAT AFTER USING LS ULTRA SENSITIVE CONDOM, SHE HAD A HORRIBLE REACTION. IT WAS ANAPHYLACTIC SHOCK AND SHE WAS PUT ON MEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103104 LIFESTYLES ULTRA SENSITIVE LUBRICATED LATEX CONDOM HIS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other