BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JIFFY POLISHER COARSE, DISK

    MDR report key: 16594775 · Received March 22, 2023

    Report

    Report Number
    1718912-2023-00002
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    December 13, 2022
    Report Date
    March 22, 2023
    Manufacturer
    UNKNOWN
    Product Code
    EHJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS DUE ON FEBRUARY 14TH, HOWEVER DUE TO IT RESTRICTIONS AND AN EXPIRED CERTIFICATE CAUSED A DELAY ON THIS REPORT SUBMISSION. ULTRADENT HAS MAINTAINED CONTACT WITH THE FDA ESG HELP DESK THROUGHOUT THAT TIME AS EVIDENCE THAT THERE WERE ESG/CERTIFICATE/IT ISSUES THAT CAUSED A DELAY.

    Description of Event or Problem · 0

    THE JIFFY POLISHER COARSE DISK (SKU 7015-) DETACHED FROM THE HAND PIECE AND WAS ASPIRATED BY THE PATIENT. THE PATIENT WAS SENT TO THE ER PER UNIVERSITY PROTOCOL. WHILE IN TRANSPORT TO THE ER, THE PATIENT EXPECTORATED THE DEVICE. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828348 JIFFY POLISHER COARSE, DISK DENTAL COMPOSITE POLISHER EHJ UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Other EVO .15 MICRO SERIES - BIEN AIR