BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX DRIVER 2.5MM AO

    MDR report key: 7105708 · Received December 11, 2017

    Report

    Report Number
    2031009-2017-00030
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    October 23, 2017
    Report Date
    October 23, 2017
    Manufacturer
    TRIMED, INC
    Product Code
    HWC
    UDI-DI
    00842188112621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO A TRIMED CUSTOMER SERVICE REPRESENTATIVE, THAT FOUR 2.5 AO HEX DRIVER'S EPOXY HAD BLED AFTER STERILIZING THE TRAY. THIS IS THE THIRD OCCURENCE OF THIS TYPE OF COMPLAINT THIS YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886416 HEX DRIVER 2.5MM AO HEX DRIVER HWC TRIMED, INC HXDRIVR-2.5AO 91957, 92238 00842188112621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown