BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLE CONDOMS

    MDR report key: 1583375 · Received January 20, 2010

    Report

    Report Number
    1019632-2010-00002
    Event Type
    Other
    Date Received
    January 20, 2010
    Report Date
    January 20, 2010
    Manufacturer
    KAREX INDUSTRIES SDN. BHD.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CUSTOMER INFORMED THAT SHE HAD ACQUIRED (B)(6) AFTER HAVING SEXUAL CONTACT WITH HER PARTNER. SHE BELIEVES THAT SHE HAD ACQUIRED THIS VIRUS IN (B)(6) 2009, AFTER ONE OF OUR CONDOMS BROKE DURING INTERCOURSE. CUSTOMER DEVELOPED GENITAL WARTS AND SOUGHT MEDICAL ATTENTION. SHE STATED THAT SHE MAY HAVE TO GO THROUGH SURGERY TO HAVE THOSE WARTS REMOVED. ON (B)(6), 2009 THIS CUSTOMER'S PARTNER SENT US A COMPLAINT STATING THAT A CONDOM BREAKAGE HAD OCCURRED DURING INTERCOURSE. SAMPLES OF CONDOMS WERE FORWARDED TO THE PROPER FACTORY AND INVESTIGATION WAS DONE ON (B)(6) 2009. RETURNED AND RETAINED SAMPLES WERE TESTED AND RESULTS WERE WITHIN SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTYLE CONDOMS LUBRICATED CONDOM HIS KAREX INDUSTRIES SDN. BHD. 05120167DT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other