BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE SALIVA EJECTOR

    MDR report key: 17008318 · Received May 25, 2023

    Report

    Report Number
    1319130-2023-00004
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    March 20, 2023
    Report Date
    May 25, 2023
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    DYN
    UDI-DI
    10732224000739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING THE REPORTED EVENT, PRODUCT RETAINS FROM THE REPORTED LOT WERE EVALUATED AND NO ISSUES WERE NOTED. DEVICES FROM THE SAME LOT WERE RETURNED TO CROSSTEX FOR EVALUATION. BASED ON THE EVALUATION, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. CROSSTEX WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT # MW5117102 THAT DURING FIVE DIFFERENT DENTAL PROCEDURES THE TIP OF THEIR ADVANTAGE SALIVA EJECTOR BROKE OFF. IN TWO CASES, THE TIP DETACHED AND WAS SWALLOWED BY THE PATIENT. THESE PATIENTS WERE ADVISED BY THE USER FACILITY TO SEEK MEDICAL ATTENTION AND LET THE FACILITY KNOW IF THERE WERE ANY ISSUES. IN THE REMAINING THREE CASES, THE TIP DETACHED AND ALL COMPONENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT'S MOUTH. THERE WAS NO REPORT OF INJURY FOR ANY OF THE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886854 ADVANTAGE SALIVA EJECTOR SALIVA EJECTOR DYN SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. ZWWI 2072334 10732224000739

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown