BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSODYNE TOOTHBRUSH

    MDR report key: 5993286 · Received October 3, 2016

    Report

    Report Number
    9615008-2016-00012
    Event Type
    Injury
    Date Received
    October 3, 2016
    Report Date
    September 28, 2016
    Manufacturer
    M + C SCHIFFER GMBH
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MFR 9615008-2016-00012 IS ASSOCIATED WITH ARGUS CASE (B)(4), SENSODYNE TOOTHBRUSH.

    Description of Event or Problem · 1

    ORTHOPEDIC SURGERY [ORTHOPEDIC PROCEDURE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ORTHOPEDIC PROCEDURE IN A MALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE TOOTHBRUSH) TOOTHBRUSH (BATCH NUMBER M5187H, EXPIRY DATE UNKNOWN) FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE TOOTHBRUSH, THE PATIENT EXPERIENCED ORTHOPEDIC PROCEDURE (SERIOUS CRITERIA HOSPITALIZATION) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ORTHOPEDIC PROCEDURE AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ORTHOPEDIC PROCEDURE TO BE RELATED TO SENSODYNE TOOTHBRUSH. ADDITIONAL DETAILS: IT WAS REPORTED THAT THE TOOTHBRUSH HAD A BROKEN HANDLE. THE PATIENT ALSO REPORTED THAT HE WAS CURRENTLY HOSPITALIZED AND WOULD BE HOSPITALIZED FOR APPROXIMATELY A MONTH AND A HALF (DETAILS UNSPECIFIED) DUE TO AN ORTHOPEDIC SURGERY THAT WILL BE PERFORMED (DETAILS UNSPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646117 SENSODYNE TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH M5187H

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization