BEUDAMED
    FDA Adverse Event Summary report: N

    OLSEN HEGAR NEEDLEHOLDERS

    MDR report key: 4919115 · Received July 16, 2015

    Report

    Report Number
    1527590-2015-00005
    Date Received
    July 16, 2015
    Date of Event
    June 15, 2015
    Report Date
    July 16, 2015
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE NEEDLE HOLDER DID NOT OPERATE PROPERLY. THE DOCTOR UTILIZED ANOTHER INSTRUMENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463963 OLSEN HEGAR NEEDLEHOLDERS NEEDLE HOLDER FHQ

    Patients

    Seq Age Sex Outcome Treatment
    1