BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAYA

    MDR report key: 8436589 · Received March 19, 2019

    Report

    Report Number
    MW5085042
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    March 17, 2019
    Report Date
    March 18, 2019
    Manufacturer
    KESSEL MEDINTIM GMBH
    Product Code
    HDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS PRESCRIBED A CAYA DIAPHRAGM, AND I NOTICED AN ERROR ON THE PACKING. THE OUTER BOX STATES, "LEAVE IN THE VAGINAL FOR LONGER THAN 24 HOURS WITHOUT INTERRUPTION." THE PACKAGING INSERT, HOWEVER, STATES IN HIGHLIGHTED, BOLD TEXT: "THE CAYA DIAPHRAGMS SHOULD NEVER BE LEFT IN THE VAGINA FOR LONGER THAN 24 HOURS [UNDERLINE] WITHOUT INTERRUPTION. WEARING IT FOR LONGER, UNINTERRUPTED PERIODS CAN PROMOTE BACTERIAL GROWTH IN THE VAGINA. THESE BACTERIA COULD LEAD TO TOXIC SHOCK SYNDROME." PLEASE ASK THE MAKERS OF CAYA TO FIX THE VERBIAGE ON THE OUTER BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227824 CAYA DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES) HDW KESSEL MEDINTIM GMBH NDC 63704-020-01 17U107L04/A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR