BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSPIRAL

    MDR report key: 1202347 · Received October 12, 2008

    Report

    Report Number
    MW5008653
    Event Type
    Other
    Date Received
    October 12, 2008
    Report Date
    October 12, 2008
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Product Code
    HIS
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON PUTTING ON AN INSPIRAL CONDOM, I NOTICED A SMALL DARK SPOT TOWARD THE TIP THAT UPON INSPECTION VIA A STRONG MAGNIFYING GLASS LOOKED LIKE A TINY INSECT, PERHAPS A FLY, EMBEDDED IN THE LATEX. I HAVE PRESERVED THE CONDOM, UNUSED OF COURSE. IN SPITE OF CONTACTING BY EMAIL BOTH MANUFACTURER AND DISTRIBUTOR WITH THIS INFORMATION, I HAVE RECEIVED NO MORE THAN AN AUTOMATED RESPONSE TELLING ME THEY HAD RECEIVED MY EMAIL. FORTUNATELY, I BECAME AWARE OF A CONTAMINATION, YET I HAVE USED THE SAME BRAND CONDOM ON OTHER OCASSIONS WITHOUT PAYING ATTENTION TO A SIMILAR PROBLEM. SO YOU CAN SEE MY CONCERN RELATING TO PERSONAL HEALTH AND TO THE CAUTIONS TAKEN IN THEIR MANUFACTURE. DATES OF USE: 2008, ABOUT 10 SECONDS. DIAGNOSIS OR REASON FOR USE: SEXUAL PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRAL CONDOM HIS MEDTECH PRODUCTS LTD. 3030701A

    Patients

    Seq Age Sex Outcome Treatment
    1