BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAFRESH MILK TEETH TOOTHBRUSH

    MDR report key: 7052603 · Received November 22, 2017

    Report

    Report Number
    9615008-2017-00015
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    October 26, 2017
    Report Date
    October 26, 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

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

    Additional Manufacturer Narrative · 1

    REPORT # 9615008-2017-00015 IS ASSOCIATED WITH (B)(4), AQUAFRESH MILK TEETH TOOTHBRUSH. AQUAFRESH MILK TEETH TOOTHBRUSH IS MARKETED AS AQUAFRESH INFANT TRAINING TOOTHBRUSH IN THE U.S.

    Description of Event or Problem · 1

    SERIOUS CHOKING HAZARD [CHOKING] ALMOST CHOKED [CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR]. 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 (AQUAFRESH MILK TEETH TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED AQUAFRESH MILK TEETH TOOTHBRUSH. ON (B)(6) 2017, AN UNKNOWN TIME AFTER STARTING AQUAFRESH MILK TEETH TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. AQUAFRESH MILK TEETH TOOTHBRUSH WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO AQUAFRESH MILK TEETH TOOTHBRUSH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PRODUCT COMPLAINT TO BE RELATED TO AQUAFRESH MILK TEETH TOOTHBRUSH. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: IT WAS REPORTED THAT "THE HEAD SNAPPED OFF WHEN SHE WAS BRUSHING HER TEETH THIS EVENING. LUCKILY SHE SPAT IT OUT, BUT IT WAS A SERIOUS CHOKING HAZARD." ON REVIEW OF INITIAL INFORMATION RECEIVED ON 26-OCT-2017 IT WAS REPORTED: 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 (AQUAFRESH MILK TEETH TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED AQUAFRESH MILK TEETH TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON (B)(6) 2017, AN UNKNOWN TIME AFTER STARTING AQUAFRESH MILK TEETH TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT AND CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR. AQUAFRESH MILK TEETH TOOTHBRUSH WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE NOT REPORTED AND THE OUTCOME OF THE CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR WAS UNKNOWN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO AQUAFRESH MILK TEETH TOOTHBRUSH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR TO BE RELATED TO AQUAFRESH MILK TEETH TOOTHBRUSH. ADDITIONAL INFORMATION: "SHE MENTIONED THAT THE HEAD OF THE TOOTHBRUSH SNAPS AND HER DAUGHTER ALMOST CHOKE BUT THE GOOD THING IS THAT SHE WAS ABLE TO SPIT IT OUT.'"

    Description of Event or Problem · 1

    SERIOUS CHOKING HAZARD [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 FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH MILK TEETH TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED AQUAFRESH MILK TEETH TOOTHBRUSH. ON (B)(6) 2017, AN UNKNOWN TIME AFTER STARTING AQUAFRESH MILK TEETH TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. AQUAFRESH MILK TEETH TOOTHBRUSH WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO AQUAFRESH MILK TEETH TOOTHBRUSH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PRODUCT COMPLAINT TO BE RELATED TO AQUAFRESH MILK TEETH TOOTHBRUSH. ADDITIONAL DETAILS: IT WAS REPORTED THAT "THE HEAD SNAPPED OFF WHEN SHE WAS BRUSHING HER TEETH THIS EVENING. LUCKILY SHE SPAT IT OUT, BUT IT WAS A SERIOUS CHOKING HAZARD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831533 AQUAFRESH MILK TEETH TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other