BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMBO-TIP EVACUATOR

    MDR report key: 8003381 · Received October 24, 2018

    Report

    Report Number
    3006008984-2018-00001
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    June 4, 2018
    Report Date
    October 24, 2018
    Manufacturer
    CROSSTEX INTERNATIONAL INC.
    Product Code
    EHZ
    PMA / PMN Number
    510(K)EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED THAT WHILE USING A CROSSTEX COMBO-TIP EVACUATOR, SHARDS OF PLASTIC PROTRUDING FROM THE TIP CAUSED THE PATIENT TO BLEED. THE CUSTOMER DID NOT RETURN THE PRODUCT FOR CROSSTEX QUALITY INVESTIGATION. LIMITED INFORMATION RELATED TO THIS COMPLAINT AND THE EXTENT OF THE REPORTED INJURIES WAS PROVIDED. THE PRODUCT WAS REPLACED WITH ANOTHER COMBO-TIP EVACUATOR. CROSSTEX HAS NOT RECEIVED ANY COMPLAINTS SIMILAR TO THIS EVENT. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE CROSSTEX COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT WHILE USING A CROSSTEX COMBO-TIP EVACUATOR, SHARDS OF PLASTIC PROTRUDING FROM THE TIP CAUSED THE PATIENT TO BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843501 COMBO-TIP EVACUATOR ORAL CAVITY EVACUATOR EHZ CROSSTEX INTERNATIONAL INC. ZET 08/31/171, 08/18/171, 04/19/17

    Patients

    Seq Age Sex Outcome Treatment
    1 Other