BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE

    MDR report key: 3131051 · Received May 23, 2013

    Report

    Report Number
    3003753847-2013-00017
    Event Type
    Injury
    Date Received
    May 23, 2013
    Report Date
    March 14, 2013
    Manufacturer
    DALIAN GOODWOOD MEDICAL CARE LTD.
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT NUMBER: 1209DG14A, EXPIRATION DATE ON: 08/31/2017.

    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 REPLACEMENT APPLICATORS RECEIVED BY THE CUSTOMER WERE FOUND TO BE DEFECTIVE AS NOTED IN THE CUSTOMER'S ORIGINAL COMPLAINT THAT THE FIBER TIP FELL OFF, AS REPORTED IN MDR 3003753847-2013-00015. THE MANUFACTURER STATED THAT IN JUNE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229416 MEDICHOICE RAYON TIPPED OB/GYN APPLICATOR KXF DALIAN GOODWOOD MEDICAL CARE LTD. 1206DG14A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention