BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURKHART PRIVATE LABEL ADVANTAGE SALIVA EJECTOR

    MDR report key: 4907329 · Received July 10, 2015

    Report

    Report Number
    2433773-2015-00001
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    July 9, 2015
    Report Date
    August 11, 2015
    Manufacturer
    CROSSTEX
    Product Code
    DYN
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED A TIP THAT FELL OFF OF A SALIVA EJECTOR DURING A DENTAL PROCEDURE. THE PATIENT ASPIRATED THE TIP AND IT LODGED IN THE PATIENT'S LUNG. SURGERY WAS REQUIRED TO REMOVE THE TIP. CROSSTEX QA AND MANUFACTURING EVALUATIONS ARE UNDERWAY AND CROSSTEX IS STILL IN CLOSE COMMUNICATION WITH THE DISTRIBUTOR. THERE ARE NO OTHER ADVERSE EVENTS RELATED TO THIS PRODUCT. PATIENT CONDITION IS UNKNOWN AT THIS TIME. THIS COMPLAINT WILL CONTINUE TO BE MONITORED AND MAINTAINED BY THE CROSSTEX COMPLAINT HANDLING SYSTEM.

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED A TIP THAT FELL OFF OF A SALIVA EJECTOR DURING A DENTAL PROCEDURE. THE PATIENT ASPIRATED THE TIP AND IT LODGED IN THE PATIENT'S LUNG. SURGERY WAS REQUIRED TO REMOVE THE TIP. CROSSTEX QA AND MANUFACTURING EVALUATIONS ARE UNDERWAY AND CROSSTEX IS STILL IN CLOSE COMMUNICATION WITH THE DISTRIBUTOR. THERE ARE NO OTHER ADVERSE EVENTS RELATED TO THIS PRODUCT. PATIENT CONDITION IS UNKNOWN AT THIS TIME. THIS COMPLAINT WILL CONTINUE TO BE MONITORED AND MAINTAINED BY THE CROSSTEX COMPLAINT HANDLING SYSTEM. A VOLUNTARY RECALL OF THE PROBLEM DEVICE LOT WAS INITIATED ON 17 JULY 2015 BY (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A TIP THAT FELL OFF OF A SALIVA EJECTOR DURING A DENTAL PROCEDURE. THE PATIENT ASPIRATED THE TIP AND IT LODGED IN THE PATIENT'S LUNG. SURGERY WAS REQUIRED TO REMOVE THE TIP.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A TIP THAT FELL OFF OF A SALIVA EJECTOR DURING A DENTAL PROCEDURE. THE PATIENT ASPIRATED THE TIP AND IT LODGED IN THE PATIENT'S LUNG. SURGERY WAS REQUIRED TO REMOVE THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450708 BURKHART PRIVATE LABEL ADVANTAGE SALIVA EJECTOR SALIVA EJECTOR DYN CROSSTEX ZWWIBK 04/10/151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R