BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUAFRESH MILK TEETH TOOTHBRUSH

    MDR report key: 5067301 · Received September 8, 2015

    Report

    Report Number
    9615008-2015-00005
    Event Type
    Other
    Date Received
    September 8, 2015
    Report Date
    April 27, 2015
    Manufacturer
    M + C SCHIFFER GMBH
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: THE ANALYSIS INCLUDES VISUAL AND MICROSCOPIC INSPECTION, VIEW OF PRODUCT REVIEW. ANCHOR POSITION, TUFT HOLE FILLING, CUT FILAMENT DIAMETER AND END ROUNDING ARE CORRECT. TUFT RETENTION FORCE IS MONITORED AND DOCUMENTED BY PRODUCTION CONTROL IN EACH SHIFT. DEVIATIONS ARE NOT DOCUMENTED. THE MICROSCOPIC INSPECTION SHOWED TRACES OF SQUASHES AT THE FILAMENT ENDS. THIS DAMAGE IS OBVIOUSLY CAUSED BY BITING ON THE FILAMENTS. INDIVIDUAL FILAMENTS OF A BUNDLE CAN THUS BE EXTRACTED DURING THE BRUSHING. THIS IS NOT ANXIOUS TO AVOID BY THIS TECHNOLOGY. IT IS MOST LIKELY THAT THE TOOTHBRUSH WAS MANUFACTURED ACCORDING TO CURRENT SPECIFICATIONS. THIS COMPLAINT IS NOT DUE TO PRODUCTION ERROR. NO CORRECTIVE ACTIONS. DECISION OF CLASSIFICATION: NON CONFIRMED. NO MFR'G ERROR HAS BEEN DETECTED.

    Description of Event or Problem · 1

    COUGHING, SICKNESS, CHOKING SENSATION, FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT. THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REP AND DESCRIBED THE OCCURRENCE OF COUGH IN A (B)(6) MONTH OLD MALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH MILK TEETH TOOTHBRUSH) FOR DENTAL CARE. 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 COUGH, SICKNESS, CHOKING SENSATION AND FOREIGN BODY IN MOUTH. THE ACTION TAKEN W/AQUAFRESH MILK TEETH TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE COUGH, SICKNESS, CHOKING SENSATION AND FOREIGN BODY IN MOUTH WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE COUGH, SICKNESS, CHOKING SENSATION AND FOREIGN BODY IN MOUTH TO BE RELATED TO AQUAFRESH MILK TEETH TOOTHBRUSH. QA RESULTS RECEIVED ON (B)(6) 2015: NON CONFIRMED. NO MFR'G ERROR HAS BEEN DETECTED. BATCH INFO UPDATED: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593121 AQUAFRESH MILK TEETH TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Other