BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANISH PAINT

    MDR report key: 920954 · Received September 28, 2007

    Report

    Report Number
    MW5003926
    Event Type
    Other
    Date Received
    September 28, 2007
    Date of Event
    September 24, 2007
    Report Date
    September 28, 2007
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    JKA
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL LIKE HAIR, LIQUID, OR BLACK PARTICLE IN ALL INDIVIDUAL PACKAGES. IT IS INVOLVED IN VARIETY OF PACKAGINGS IN DIFFERENT LOCATIONS. THERE WAS NO PT INVOLVEMENT. THE REPORTER STATED THAT THEY CONTACTED MFR AND ALLEGEDLY, IT IS STILL UNDER INVESTIGATION. THE LOCAL DISTRIBUTER WAS ALSO INFORMED AND THEY OFFERED TO SEND REPLACEMENT BUT CONSUMER DECLINED, BECAUSE THEY SAID IT MIGHT BE CONTAMINATED AS WELL, OR MIGHT BE SAME LOT # AS MANY LOT NUMBERS INVOLVED IN IT. THE REPORTER PROVIDED 2 SPECIFIC LOT #S AS FOLLOWS: LOT # A070202, LOT # A270102.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANISH PAINT SYRINGE JKA RETRACTABLE TECHNOLOGIES, INC. A070202
    2 VANISH PAINT SYRINGE JKA RETRACTABLE TECHNOLOGIES, INC. AZ70102

    Patients

    Seq Age Sex Outcome Treatment
    1 YR