BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE

    MDR report key: 3131072 · Received May 23, 2013

    Report

    Report Number
    3003753847-2013-00005
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 10, 2012
    Manufacturer
    DALIAN GOODWOOD MEDICAL CARE LTD.
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    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 APPLICATORS WERE FALLING APART. THE MANUFACTURER STATED THAT IN (B)(6) 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 APPLICATOR FALLING APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230375 MEDICHOICE RAYON TIPPED OB/GYN APPLICATOR KXF DALIAN GOODWOOD MEDICAL CARE LTD. 1209DG13A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention