BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACLEANS MULTI ACTION TOOTHBRUSH

    MDR report key: 5820742 · Received July 25, 2016

    Report

    Report Number
    9615008-2016-00009
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    July 15, 2016
    Report Date
    July 18, 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
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH (B)(4), MACLEANS MULTI ACTION TOOTHBRUSH. MACLEANS MULTI ACTION TOOTHBRUSH IS MARKETED AS AQUAFRESH IN THE US.

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION INCLUDES QA RESULTS WHICH WERE INADVERTENTLY OMITTED FROM THE LAST REPORT SUBMITTED ON 18 AUGUST 2016.

    Description of Event or Problem · 1

    CHOKING [CHOKING]. GAGGING [GAGGING]. DISCOMFORT [DISCOMFORT]. "BRISTLES AND MIDDLE SECTION LODGED IN MOUTH"/ "BRISTLES AND MIDDLE SECTION LODGED IN THROAT". [FOREIGN BODY IN GI TRACT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6) MALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (MACLEANS MULTI ACTION TOOTHBRUSH) TOOTHBRUSH FOR ORAL HYGIENE. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED MACLEANS MULTI ACTION TOOTHBRUSH (DENTAL) AT AN UNKNOWN DOSE AND FREQUENCY. ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING MACLEANS MULTI ACTION TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), GAGGING, DISCOMFORT AND FOREIGN BODY IN GI TRACT. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. MACLEANS MULTI ACTION TOOTHBRUSH WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, GAGGING, DISCOMFORT AND FOREIGN BODY IN GI TRACT WERE RECOVERED/RESOLVED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING, GAGGING, DISCOMFORT AND FOREIGN BODY IN GI TRACT TO BE RELATED TO MACLEANS MULTI ACTION TOOTHBRUSH. ADDITIONAL DETAILS, THE CONSUMER REPORTED A COMPLAINT ABOUT THE SUSPECT PRODUCT (MEDIUM). HE STATED THAT THE LAST PORTION OF THE CENTRE BRISTLES TEND TO FALL OFF WHICH LEAD TO THEM ACCUMULATING IN HIS MOUTH, RESULTING IN CHOKING AND GAGGING. HE STARTED EXPERIENCING CHOKING/GAGGING AFTER USING THE PRODUCT ON (B)(6) 2016. THE CONSUMER STATED THAT HE HAS TWO TOOTHBRUSHES, ONE WAS USED THREE TIMES WHICH LEAD TO THE BRISTLES FALLING OFF, THE OTHER HAD BEEN USED TWICE AND WAS STILL INTACT. HE MENTIONED THAT HE NO LONGER WANTS TO USE THE PRODUCT ANYMORE SINCE ITS DESIGN IS PRONE TO THIS ISSUE. CONSUMER CONFIRMED HE WAS FINE AT THE MOMENT. THE PATIENT REPORTED THAT HE RECENTLY PURCHASED 2 MACLEANS MULTI ACTION TOOTHBRUSHES, AFTER THE 3RD USAGE OF 1 BRUSH THE CENTRE SECTION BUSTED OUT OF THE BRUSH, AT THE END SET OF BRISTLES CLOSER THE HANDLE END, RESULTING IN THAT SET OF BRISTLES AND THE MIDDLE SECTION TO BE LODGED IN HIS MOUTH AND THROAT, CAUSING HIM MUCH DISCOMFORT, YES NO NEED TO GO ON. THE PATIENT STATED THAT "NOT BEING A TOOTH BRUSH DESIGNER OR ENGINEER I MUST STILL MAKE A COMMENT AFTER I EXAMINED THE REMAINS, I FOUND THIS AREA TO BE EXTREMELY INEFFECTIVE IN STRENGTH DESIGN".

    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) MALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (MACLEANS MULTI ACTION TOOTHBRUSH) TOOTHBRUSH FOR ORAL HYGIENE. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED MACLEANS MULTI ACTION TOOTHBRUSH (DENTAL) AT AN UNKNOWN DOSE AND FREQUENCY. ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING MACLEANS MULTI ACTION TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), GAGGING, DISCOMFORT AND FOREIGN BODY IN GI TRACT. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. MACLEANS MULTI ACTION TOOTHBRUSH WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, GAGGING, DISCOMFORT AND FOREIGN BODY IN GI TRACT WERE RECOVERED/RESOLVED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING, GAGGING, DISCOMFORT AND FOREIGN BODY IN GI TRACT TO BE RELATED TO MACLEANS MULTI ACTION TOOTHBRUSH. ADDITIONAL DETAILS, THE CONSUMER REPORTED A COMPLAINT ABOUT THE SUSPECT PRODUCT (MEDIUM). HE STATED THAT THE LAST PORTION OF THE CENTRE BRISTLES TEND TO FALL OFF WHICH LEAD TO THEM ACCUMULATING IN HIS MOUTH, RESULTING IN CHOKING AND GAGGING. HE STARTED EXPERIENCING CHOKING/GAGGING AFTER USING THE PRODUCT ON (B)(6) 2016. THE CONSUMER STATED THAT HE HAS TWO TOOTHBRUSHES, ONE WAS USED THREE TIMES WHICH LEAD TO THE BRISTLES FALLING OFF, THE OTHER HAD BEEN USED TWICE AND WAS STILL INTACT. HE MENTIONED THAT HE NO LONGER WANTS TO USE THE PRODUCT ANYMORE SINCE ITS DESIGN IS PRONE TO THIS ISSUE. CONSUMER CONFIRMED HE WAS FINE AT THE MOMENT. THE PATIENT REPORTED THAT HE RECENTLY PURCHASED 2 MACLEANS MULTI ACTION TOOTHBRUSHES, AFTER THE 3RD USAGE OF 1 BRUSH THE CENTRE SECTION BUSTED OUT OF THE BRUSH, AT THE END SET OF BRISTLES CLOSER THE HANDLE END, RESULTING IN THAT SET OF BRISTLES AND THE MIDDLE SECTION TO BE LODGED IN HIS MOUTH AND THROAT, CAUSING HIM MUCH DISCOMFORT, YES NO NEED TO GO ON. THE PATIENT STATED THAT "NOT BEING A TOOTH BRUSH DESIGNER OR ENGINEER I MUST STILL MAKE A COMMENT AFTER I EXAMINED THE REMAINS, I FOUND THIS AREA TO BE EXTREMELY INEFFECTIVE IN STRENGTH DESIGN". FOLLOW UP RECEIVED FROM QA ON 02 AUG 2016 THE QA ANALYSIS FOUND THE COMPLAINT WAS UNDETERMINED. FOLLOW UP RECEIVED FROM QA ON 12 AUG 2016 THE COMPLAINT WAS UNSUBSTANTIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473717 MACLEANS MULTI ACTION TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other