BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE

    MDR report key: 3131059 · Received May 23, 2013

    Report

    Report Number
    3003753847-2013-00012
    Event Type
    Injury
    Date Received
    May 23, 2013
    Report Date
    February 1, 2013
    Manufacturer
    DALIAN GOODWOOD MEDICAL CARE LTD.
    Product Code
    KXF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE MEDICAL DEVICE ASSOCIATED WITH THIS REPORT IS A NON-STERILE, RAYON-FIBER TIPPED APPLICATOR (OB/GYN) CONSISTING OF A PLASTIC STICK AND THE RAYON-FIBER BUD. IT WAS COMMUNICATED THAT THE TIP COMES OFF WITH ANY KIND OF PRESSURE, DRY OR WET. THE CUSTOMER STATED THAT IT WAS UNSAFE TO PATIENTS TO HAVE THE END OF THE TIP COME OFF INSIDE THE VAGINA. THE MANUFACTURER STATED THAT IN (B)(4) 2011, THEY REDUCED THE CONCENTRATION OF GLUE WHICH WAS USED TO SECURE THE RAYON TIP TO THE PLASTIC SHAFT. THE LOW CONCENTRATION OF GLUE USED TO SECURE THE RAYON TIP TO THE PLASTIC SHAFT WAS DETERMINED TO BE THE MOST PROBABLE ROOT CAUSE OF THE TIP COMING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230410 MEDICHOICE RAYON TIPPED OB/GYN APPLICATOR KXF DALIAN GOODWOOD MEDICAL CARE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention