BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSODYNE PRONAMEL SOFT TOOTHBRUSH

    MDR report key: 6865437 · Received September 14, 2017

    Report

    Report Number
    9615008-2017-00013
    Event Type
    Injury
    Date Received
    September 14, 2017
    Report Date
    August 29, 2017
    Manufacturer
    M + C SCHIFFER GMBH
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 9615008-2017-00013 IS ASSOCIATED WITH ARGUS CASE (B)(4), SENSODYNE PRONAMEL SOFT TOOTHBRUSH.

    Description of Event or Problem · 1

    NEARLY CHOKED [CHOKING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE PRONAMEL SOFT TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE PRONAMEL SOFT TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE PRONAMEL SOFT TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE PRONAMEL SOFT TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE PRONAMEL SOFT TOOTHBRUSH. ADDITIONAL DETAILS: THE PATIENT PURCHASED A SENSODYNE PRONAMEL SOFT TOOTHBRUSH AND THE FIRST TIME SHE BRUSHED HER TEETH WITH IT ONE OF THE BUNCHES OF BRISTLES FELT OUT AND SHE NEARLY CHOKED ON IT. SHE USED THE BRUSH FOR A SECOND TIME AND A FEW MORE OF THE BRISTLES FELL OUT. SHE WAS RAISING THIS ISSUE AS SHE WAS NOT SURE WHY THIS HAPPENED AND IN CASE IT HAPPENED TO SOMEONE ELSE WITH A DIFFERENT OUTCOME. IT MIGHT JUST BE A PROBLEM WITH THIS BATCH OF BRUSHES AS SHE HAD USED THIS TYPE OF BRUSH BEFORE. FOLLOW UP INFORMATION WAS RECEIVED ON 11 SEP 2017. THIS CASE HAD BEEN RE-ROUTED UNDER A NEW REFERENCE NUMBER: (B)(4). THIS WAS BECAUSE AN INCORRECT COUNTRY OF OCCURRENCE WAS CAPTURED AS (B)(6) BUT SHOULD BE (B)(6) AS THE REPORTER IS FROM THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644288 SENSODYNE PRONAMEL SOFT TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other