BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30 G SHORT PLASTIC

    MDR report key: 3043349 · Received March 8, 2013

    Report

    Report Number
    1017768-2013-00006
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 21, 2013
    Product Code
    DZM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DENTAL NEEDLE. THE CUSTOMER REPORTS THE NEEDLE DETACHED FROM THE HUB INTO THE PT MOUTH. THE NEEDLE WAS NOT ABLE TO BE REMOVED BY THE DENTIST AT THAT TIME. THE PT WAS REFERRED TO AN ORAL SURGEON. THE PT WAS HOSPITALIZED AND UNDERWENT OUTPATIENT SURGERY TO REMOVE THE NEEDLE. THE NEEDLE WAS NOT ABLE TO BE REMOVED DURING THE SURGERY, BECAUSE OF THE AREA, AND THE AMOUNT OF BLOOD VESSELS THE SURGEON DID NOT PROCEED, THEY FELT THAT DOING MORE WAS TOO RISKY. THE DENTIST ADVISED THAT THEY ARE GOING TO MONITOR THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100701 30 G SHORT PLASTIC DENTAL NEEDLE DZM 8881400074 226137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R