BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAFRESH MILK TEETH TOOTHBRUSH

    MDR report key: 6529291 · Received April 28, 2017

    Report

    Report Number
    9615008-2017-00006
    Event Type
    Injury
    Date Received
    April 28, 2017
    Report Date
    April 17, 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

    THE 9615008-2017-00006 IS ASSOCIATED WITH ARGUS CASE (B)(4), AQUAFRESH MILK TEETH TOOTHBRUSH. AQUAFRESH MILK TEETH TOOTHBRUSH WAS MARKETED AS AQUAFRESH INFANT TRAINING TOOTHBRUSH IN THE US. DEVICE QA RESULTS AS OF 21 APRIL 2017: AS THE BATCH DETAILS OR SAMPLE WERE UNAVAILABLE FOR THIS COMPLAINT, A FULL INVESTIGATION COULD NOT BE COMPLETED. AS THIS INFORMATION IS NOT AVAILABLE, THE COMPLAINT CANNOT BE SUBSTANTIATED.

    Additional Manufacturer Narrative · 1

    (B)(4) IS ASSOCIATED WITH (B)(4), AQUAFRESH MILK TEETH TOOTHBRUSH. AQUAFRESH MILK TEETH TOOTHBRUSH WAS MARKETED AS AQUAFRESH INFANT TRAINING TOOTHBRUSH IN THE US.

    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)-OLD MALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH MILK TEETH TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED AQUAFRESH MILK TEETH TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING AQUAFRESH MILK TEETH TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH AQUAFRESH MILK TEETH 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 AQUAFRESH MILK TEETH TOOTHBRUSH. ADDITIONAL DETAILS, ADVERSE EVENT REPORTED TO (B)(4) SAFETY VIA CUSTOMER RELATIONS BY A PATIENT'S MOTHER ON BEHALF OF HER SON. CONSUMER BOUGHT TOOTHBRUSHES FOR HER CHILDREN FOR YEARS AND NEVER HAD A PROBLEM. HOWEVER LAST WEEK SHE BOUGHT ONE OF BABY TOOTHBRUSHES FOR HER (B)(6) OLD BABY. THE BRISTLES KEPT FALLING OUT AND HE ACTUALLY NEARLY CHOKED ON ONE. THIS CASE WAS ALSO ASSOCIATED WITH PRODUCT COMPLAINT AS IT HAD BEEN REPORTED THAT THE BRISTLES KEPT FALLING OUT. QA REPORT RECEIVED ON 21-APR-2017: THIS PRODUCT COMPLAINT WAS UNSUBSTANTIATED.

    Description of Event or Problem · 1

    NEARLY CHOCKED/HE ACTUALLY NEARLY CHOKED ON ONE [CHOKING] CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6)-OLD MALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH MILK TEETH TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED AQUAFRESH MILK TEETH TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING AQUAFRESH MILK TEETH TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH AQUAFRESH MILK TEETH 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 AQUAFRESH MILK TEETH TOOTHBRUSH. ADDITIONAL DETAILS, ADVERSE EVENT REPORTED TO (B)(4) SAFETY VIA CUSTOMER RELATIONS BY A PATIENT'S MOTHER ON BEHALF OF HER SON. CONSUMER BOUGHT TOOTHBRUSHES FOR HER CHILDREN FOR YEARS AND NEVER HAD A PROBLEM. HOWEVER LAST WEEK SHE BOUGHT ONE OF BABY TOOTHBRUSHES FOR HER 14 MONTH OLD BABY. THE BRISTLES KEPT FALLING OUT AND HE ACTUALLY NEARLY CHOKED ON ONE. THIS CASE WAS ALSO ASSOCIATED WITH PRODUCT COMPLAINT AS IT HAD BEEN REPORTED THAT THE BRISTLES KEPT FALLING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310511 AQUAFRESH MILK TEETH TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Other