BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREPSTART

    MDR report key: 6799440 · Received August 16, 2017

    Report

    Report Number
    2023950-2017-00255
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    July 17, 2017
    Report Date
    October 18, 2017
    Manufacturer
    DANVILLE MATERIALS
    Product Code
    KOJ
    PMA / PMN Number
    K970589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL EVALUATION OF DEVICE WAS PERFORMED. WEAR OF THE PINCH VALVE SPING AND FOOT PEDAL VALVE WAS OBSERVED. PROBABLE CAUSE: INSTRUCTIONS FOR USE INDICATES THAT EYE PROTECTION SHOULD BE WORN BY PATIENT AND STAFF DURING AIR ABRASIAN USE. PATIENT WAS NOT WEARING PROTECTIVE EYEWEAR DURING AIR ABRASIAN USE. (B)(4) MATERIALS REPRESENTATIVE FOLLOWED-UP WITH PATIENT STATUS. PATIENT FOLLOWED EYE WASH PROTOCOL FOR 3 MINUTES WITH NO COMPLICATIONS. INSTRUCTION FOR USE ALSO INDICATES THAT THE PINCH VALVE SHOULD BE INSPECTED AFTER EVERY 6 MONTHS OF USE FOR SIGNS OF WEAR. UNDER NORMAL USE THE PREPSTART PINCH VALVE TUBE WILL LAST A MINIMUM OF ONE YEAR. PROBABLE CAUSE OF WORN VALVES MAY BE BECAUSE OF FAILURE TO INSPECT THE VALVES FOR SIGNS OF WEAR.

    Additional Manufacturer Narrative · 1

    FINAL EVALUATION OF DEVICE WAS PERFORMED. WEAR OF THE PINCH VALVE SPING AND FOOT PEDAL VALVE WAS OBSERVED. PROBABLE CAUSE: INSTRUCTIONS FOR USE INDICATES THAT EYE PROTECTION SHOULD BE WORN BY PATIENT AND STAFF DURING AIR ABRASIAN USE. PATIENT WAS NOT WEARING PROTECTIVE EYEWEAR DURING AIR ABRASIAN USE. (B)(4) MATERIALS REPRESENTATIVE FOLLOWED-UP WITH PATIENT STATUS. PATIENT FOLLOWED EYE WASH PROTOCOL FOR 3 MINUTES WITH NO COMPLICATIONS. INSTRUCTION FOR USE ALSO INDICATES THAT THE PINCH VALVE SHOULD BE INSPECTED AFTER EVERY 6 MONTHS OF USE FOR SIGNS OF WEAR. UNDER NORMAL USE THE PREPSTART PINCH VALVE TUBE WILL LAST A MINIMUM OF ONE YEAR. PROBABLE CAUSE OF WORN VALVES MAY BE BECAUSE OF FAILURE TO INSPECT THE VALVES FOR SIGNS OF WEAR.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT THERE WAS A HEAVY EXC ESS FLOW OF ALUMINUM OXIDE WHEN THE PEDAL WAS STEPPED-ON. CUSTOMER INDICATED THAT ALUMINUM OXIDE MATERIAL REACHED THE PATIENT'S EYES. THE PATIENT WAS NOT WEARING PROTECTIVE EYEWEAR.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT THERE WAS A HEAVY EXCESS FLOW OF ALUMINUM OXIDE WHEN THE PEDAL WAS STEPPED-ON. CUSTOMER INDICATED THAT ALUMINUM OXIDE MATERIAL REACHED THE PATIENT'S EYES. THE PATIENT WAS NOT WEARING PROTECTIVE EYEWEAR.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT THERE WAS A HEAVY EXCESS FLOW OF ALUMINUM OXIDE WHEN THE PEDAL WAS STEPPED-ON. CUSTOMER INDICATED THAT ALUMINUM OXIDE MATERIAL REACHED THE PATIENT'S EYES. THE PATIENT WAS NOT WEARING PROTECTIVE EYEWEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578110 PREPSTART AIRBRUSH KOJ DANVILLE MATERIALS 200259-00 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R