BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFY

    MDR report key: 8046489 · Received November 6, 2018

    Report

    Report Number
    MW5081133
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    October 22, 2018
    Report Date
    November 2, 2018
    Manufacturer
    STRAUSS DIAMOND INSTRUMENT / STRAUSS & CO.
    Product Code
    DZP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY ORTHODONTIST USE A DEVICE CALLED "ACTIFY" ON MY BONE TO MAKE MY TEETH MOVE FASTER. I WAS GIVEN A NUMBING SHOT DURING THE TREATMENT, BUT IT HURT SO BAD AND NEVER STOPPED BLEEDING. MY DR SAID IT WAS BECAUSE THE SCREW WAS TOO BIG. I HAVE RAISED AREA OF BONE AROUND EACH PLACE. HE USED THIS DEVICE AND IT STILL HURTS NOW. I HAVE TO GO TO ORAL SURGEON TO GET CHECKED OUT. THIS DOESN'T SEEM RIGHT TO ME. I ASKED THE DR FOR INFO ON THE COMPANY AND SAFETY LABELS, HE SHOWED A TUBE WITH A SCREW WITH NO LABELS OR INSTRUCTIONS. THIS CAN'T BE RIGHT AND SAFE. HTTPS://STRAUSSDIAMOND.COM/PRODUCT/ACTIFY. THIS IS WEBSITE FOR THE PRODUCT THAT WAS USED ON ME AND I DON'T THINK IT IS A SAFE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884899 ACTIFY INSTRUMENT, DIAMOND, DENTAL DZP STRAUSS DIAMOND INSTRUMENT / STRAUSS & CO. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention