BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN/ACCLEAN

    MDR report key: 17683704 · Received September 5, 2023

    Report

    Report Number
    1051594-2023-00001
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    January 20, 2023
    Report Date
    August 30, 2023
    Manufacturer
    GLOBAL DENT AIDS PRIVATE LIMITED
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONSUMER DID NOT SEEK TREATMENT. CONSUMER PURCHASED INTERDENTAL AT PARK SLOP COOP INC 782 UNION ST BROOKLYN, NY 11215. INITIAL REPORT FOR FOREIGN MANUFACTURER (GDA) (153281 REORDER#). INITIAL REPORT FOR IMPORTER/REPACKAGER/RELABELER (TTI) (753220 REORDER#). INITIAL REPORT FOR DISTRIBUTOR (HS) ((B)(4) REORDER#).

    Description of Event or Problem · 0

    PER (B)(6), THE INTERDENTAL WAS PURE METAL AND CUT GUMS. NO ADDITIONAL DETAILS (LOT, PHOTO,SAMPLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006427 HENRY SCHEIN/ACCLEAN INTERDENTAL TRAVEL BRUSH EFW GLOBAL DENT AIDS PRIVATE LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Female