BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPREP DIRECTOR+

    MDR report key: 1486003 · Received September 25, 2009

    Report

    Report Number
    2916440-2009-00001
    Event Type
    Injury
    Date Received
    September 25, 2009
    Date of Event
    September 16, 2009
    Report Date
    September 25, 2009
    Manufacturer
    LARES RESEARCH, INC.
    Product Code
    KOJ
    PMA / PMN Number
    K932997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IN 2009: DR. WAS USING THE AIR ABRASION UNIT ON A GIRL. DURING THE PROCEDURE, HER CHEEK WAS LACERATED, AND SHE HAD WHAT APPEARED TO BE A HYPERSENSITIVITY REACTION WITH EYE SWELLING. THE SYMPTOMS WORSENED WITH FURTHER SWELLING AND "WRINKLING AND CRINKLING, ALMOST LIKE RICE KRISPIES" DOWN INTO HER NECK. THE GIRL SPENT THE NIGHT IN THE PEDIATRIC INTENSIVE CARE UNIT AT THE HOSPITAL. AS OF THIS MORNING, DR. STATED THAT HER CONDITION HAS IMPROVED, AND IS DUE TO BE RELEASED FROM THE HOSPITAL THIS AFTERNOON. I TOLD HIM WE WOULD CALL IF ANY ADDITIONAL INFORMATION WAS NEEDED. DR. ACKNOWLEDGED KNOWING THAT ALUMINUM OXIDE IS HARMLESS, AND HE DIDN'T NEED ANOTHER MSDS SHEET SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPREP DIRECTOR+ DENTAL AIR ABRASION UNIT/ AIRBRUSH; KOJ KOJ LARES RESEARCH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization