BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONFORM PLUS PF STYLE 319

    MDR report key: 774043 · Received October 25, 2006

    Report

    Report Number
    1019632-2006-00008
    Event Type
    Other
    Date Received
    October 25, 2006
    Date of Event
    October 23, 2006
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Product Code
    FMC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A STAFF NURSE PUT THE GLOVE ON TO USE IT AND CUT HER FINGER BECAUSE A PIECE OF GLASS WAS IN THE RIGHT HAND. MIDDLE FINGER OF THE GLOVE. THE END USER SAID THE GLASS PIECE WAS ABOUT 1 CM LONG AND 1 1/2 CM WIDE. THE NURSE DID CUT HER FINGER. THE AREA WAS CLEANED AND SOME LAB WORK PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFORM PLUS PF STYLE 319 EXAM GLOVE FMC PERUSAHAAN GETAH ASAS SDN BHD * 06061022EP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other