BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANTEC

    MDR report key: 5659636 · Received May 17, 2016

    Report

    Report Number
    3004827015-2016-00005
    Event Type
    Injury
    Date Received
    May 17, 2016
    Report Date
    May 17, 2016
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    IKT
    PMA / PMN Number
    K931966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DOCTOR HAS STUCK HIMSELF WITH A NEEDLE DUE TO DEFECTIVE NEEDLES. THIS IS THE SECOND REPORT OF THIS EVENT FROM THE SAME CUSTOMER. (THE FIRST WAS REPORTED IN REPORT #3004827015-2016-00004). THE CUSTOMER DID NOT PROVIDE ANY FURTHER NARRATIVE ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315939 DANTEC DISPOSABLE CONCENTRIC NEEDLE IKT ALPINE BIOMED APS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention