BEUDAMED
    FDA Adverse Event Summary report: N

    POWER PROXI BATTERY OPERATED SONIC INTERDENTAL SYSTEM

    MDR report key: 32677 · Received May 3, 1996

    Report

    Report Number
    MW4001171
    Date Received
    May 3, 1996
    Report Date
    April 8, 1996
    Manufacturer
    DENTIST PREFERRED, INC.
    Product Code
    EFS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT REPORTS THAT UPON USING SUBJECT DEVICE'S ATTACHMENT WHICH SHE DESCRIBED AS A "PICK," "WIRE," OR "FLOSS" BRUSH, IT BECAME STUCK BETWEEN HER TOOTH AND GUM CAUSING HER RECURRING PAIN AND WHAT HER DENTIST DESCRIBED AS "IRREPARABLE BONE DAMAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PROXI BATTERY OPERATED SONIC INTERDENTAL SYSTEM ORAL IRRIGATION UNIT EFS DENTIST PREFERRED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO