BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANTI

    MDR report key: 40730 · Received September 4, 1996

    Report

    Report Number
    1045600-1996-00001
    Event Type
    Other
    Date Received
    September 4, 1996
    Date of Event
    August 12, 1996
    Report Date
    August 28, 1996
    Manufacturer
    LONDON INTL GROUP, PLC
    Product Code
    HIS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER ALLEGES FIRST CONDOM BROKE ON INSERTION AND HE NOTICED A HOLE IN SECOND CONDOM AFTER COMPLETION. CONSUMER IS CONCERNED ABOUT THE POSSIBILITY OF CONTACTING HERPES AND A POTENTIAL PREGNANCY AFTER HAVING INTERCOURSE WITH A FEMALE PARTNER THAT MAY HAVE HAD AN ACTIVE HERPES LESION. HE STATED THAT HE HAD NOT SOUGHT A MEDICAL OPINION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTI POLYURETHANE CONDOM HIS LONDON INTL GROUP, PLC AVANTI MFG 51495

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other