BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUAFRESH BIG TEETH TOOTHBRUSH

    MDR report key: 5044600 · Received August 28, 2015

    Report

    Report Number
    9615008-2015-00004
    Event Type
    Other
    Date Received
    August 28, 2015
    Date of Event
    August 13, 2015
    Report Date
    August 13, 2015
    Manufacturer
    M AND C SCHIFFER GMBH
    Product Code
    EFW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALMOST CHOKED. 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 BIG TEETH TOOTHBRUSH) TOOTHBRUSH (BATCH NO. S5099H, EXPIRY DATE UNK) FOR PRODUCT USED FOR UNK INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED ILL-DEFINED DISORDER (SEVERE SPECIAL NEEDS PATIENT AND IS NOT VERBAL). ON (B)(6) 2015, THE PATIENT STARTED AQUAFRESH BIG TEETH TOOTHBRUSH AT AN UNK DOSE AND FREQUENCY. ON (B)(6) 2015, AN UNK TIME AFTER STARTING AQUAFRESH BIG TEETH TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH AQUAFRESH BIG TEETH TOOTHBRUSH WAS UNK. ON (B)(6) 2015, THE OUTCOME OF THE CHOKING WAS NOT REPORTED. IT WAS UNK IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO AQUAFRESH BIG TEETH TOOTHBRUSH. ADD'L. INFO: THE MOTHER REPORTED THAT HER DAUGHTER WITH SEVERE SPECIAL NEEDS ALMOST CHOKED ON THE BRISTLES OF THE AQUAFRESH BIG TEETH TOOTHBRUSH BY BITING INTO THE HEAD OF THE BRUSH. HER DAUGHTER CONTINUED TO CHEW THE END, FOR SOMETIME BEFORE SHE WAS ABLE TO REMOVE IT FROM HER MOUTH. THIS THE FIRST TIME SHE HAD USED AQUAFRESH BIG TEETH TOOTHBRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573480 AQUAFRESH BIG TEETH TOOTHBRUSH TOOTHBRUSHES EFW M AND C SCHIFFER GMBH S5099H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other