BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEDYNE WATER PIK

    MDR report key: 66721 · Received January 30, 1997

    Report

    Report Number
    1712259-1997-00002
    Event Type
    Injury
    Date Received
    January 30, 1997
    Date of Event
    December 31, 1996
    Report Date
    January 30, 1997
    Manufacturer
    TELEDYNE WATER PIK
    Product Code
    EFS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT WAS VERY DIRTY. ALL PERFORMANCE VALUES WERE IN SPEC. EXCEPT FOR HIGH PRESSURE THAT WAS 68PSI WHEN COMPARED TO THE SPECIFICATION - 75PSI MINIMUM.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO STATE THAT THE ORAL IRRIGATOR FORCED FOOD DEBRIS UNDER HER DENTAL WORK CAUSING DAMAGE TO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEDYNE WATER PIK ORAL IRRIGATOR EFS TELEDYNE WATER PIK WP-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability