BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAFRESH FLEX TOOTHBRUSH

    MDR report key: 5377425 · Received January 19, 2016

    Report

    Report Number
    9615008-2016-00001
    Event Type
    Injury
    Date Received
    January 19, 2016
    Report Date
    January 7, 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
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT 9615008-2016-00001 IS ASSOCIATED WITH (B)(4) AQUAFRESH FLEX TOOTHBRUSH. QA RESULTS: THE ANALYSIS INCLUDES VISUAL AND MICROSCOPIC INSPECTION, VIEW OF PRODUCT REVIEW. TRACES OF BITES SHOW THAT OBVIOUSLY CHEWING ON THE BRUSH HEAD DURING BRUSHING THE TEETH. THE MIDDLE FINGER SHOW OVERSTRETCHING IN DIRECTION OF NORMAL PRESSURE. VERY PROBABLY THE MIDDLE FINGER WAS DESTROYED BY TURNING THEM BY 90 DEGREES VERTICAL. DUE TO THE FACT ONE BUNDLE HOLE WAS SQUEEZED AND DESTRUCTED WITH THE EFFECT THAT THE FILAMENTS AT THIS BUNDLE HOLE HAVE FALLEN OUT. THE DAMAGE HAS TO BE LED BACK ON A MECHANICAL OVERLOAD, CAUSED BY AN UNORDINARY USING. WE CONFIRMED THE PRODUCTION OF THE MANUFACTURER IN ACCORDANCE WITH THE SPECIFICATIONS. THERE IS NO MANUFACTURING ERROR VISIBLE.

    Additional Manufacturer Narrative · 1

    THE 9615008-2016-00001 IS ASSOCIATED WITH (B)(4) AQUAFRESH FLEX TOOTHBRUSH.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH FLEX TOOTHBRUSH) TOOTHBRUSH FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED AQUAFRESH FLEX TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, LESS THAN A MINUTE AFTER STARTING AQUAFRESH FLEX TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH AQUAFRESH FLEX TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO AQUAFRESH FLEX TOOTHBRUSH. ADDITIONAL DETAILS: THE PATIENT'S MOUTH WAS FULL OF SMALL WHITE BRISTLES. SHE HAD TO "CHOKE" THE REMAINING BRISTLES FROM THE BACK OF HER THROAT. FOLLOW-UP INFORMATION RECEIVED ON 26 JANUARY 2016: THE BATCH NUMBER WAS REPORTED AS M42642000. FOLLOW UP INFORMATION RECEIVED ON 03 MARCH 2016: THE FACTORY REPORT WAS COMPLETED AND THE COMPLAINT WAS UNSUBSTANTIATED.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6) FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH FLEX TOOTHBRUSH) TOOTHBRUSH FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED AQUAFRESH FLEX TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, LESS THAN A MINUTE AFTER STARTING AQUAFRESH FLEX TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH AQUAFRESH FLEX TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO AQUAFRESH FLEX TOOTHBRUSH. ADDITIONAL DETAILS: THE PATIENT'S MOUTH WAS FULL OF SMALL WHITE BRISTLES. SHE HAD TO "CHOKE" THE REMAINING BRISTLES FROM THE BACK OF HER THROAT. FOLLOW-UP INFORMATION RECEIVED ON 26 JANUARY 2016: THE BATCH NUMBER WAS REPORTED AS M42642000.

    Description of Event or Problem · 1

    CHOKED [CHOKING]. PRODUCT COMPLAINT [PRODUCT COMPLAINT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6) FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH FLEX TOOTHBRUSH) TOOTHBRUSH FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED AQUAFRESH FLEX TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, LESS THAN A MINUTE AFTER STARTING AQUAFRESH FLEX TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH AQUAFRESH FLEX TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO AQUAFRESH FLEX TOOTHBRUSH. ADDITIONAL DETAILS: THE PATIENT'S MOUTH WAS FULL OF SMALL WHITE BRISTLES. SHE HAD TO "CHOKE" THE REMAINING BRISTLES FROM THE BACK OF HER THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34945 AQUAFRESH FLEX TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH M42642000

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other