BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSODYNE PRONAMEL TOOTHBRUSH

    MDR report key: 6181140 · Received December 16, 2016

    Report

    Report Number
    9615008-2016-00014
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    October 29, 2016
    Report Date
    October 29, 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
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), SENSODYNE PRONAMEL TOOTHBRUSH. DEVICE QA RESULTS: UNSUBSTANTIATED. A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, THE REVIEW OF MANUFACTURING/PACKAGING BATCH RECORDS IS NOT POSSIBLE DUE TO LACK OF BATCH NUMBER.

    Additional Manufacturer Narrative · 1

    9615008-2016-00014 IS ASSOCIATED WITH ARGUS CASE CA2016GSK162763, SENSODYNE PRONAMEL TOOTHBRUSH.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF GAGGING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE PRONAMEL TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED SENSODYNE UNKNOWN, GSK TOOTHBRUSH (SENSODYNE TOOTHBRUSH), GSK TOOTHBRUSH (SENSODYNE SENSITIVE TOOTHBRUSH) AND POTASSIUM NITRATE, SODIUM FLUORIDE (SENSODYNE ULTRA FRESH). ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE PRONAMEL TOOTHBRUSH. ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING SENSODYNE PRONAMEL TOOTHBRUSH, THE PATIENT EXPERIENCED GAGGING AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE PRONAMEL TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE GAGGING WAS NOT REPORTED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE GAGGING TO BE RELATED TO SENSODYNE PRONAMEL TOOTHBRUSH. ADDITIONAL DETAILS, THE CONSUMER REPORTED THAT SHE HAD USED SENSODYNE(CONCOMITANT) FOR MANY YEARS AND HAD BEEN VERY SATISFIED WITH SENSODYNE TOOTHBRUSHES(CONCOMITANT) AS WELL. THE CONSUMER REPORTED THAT HER LAST TOOTHBRUSH PURCHASE WAS SENSODYNE PRONAMEL WHICH SHE HAD NEVER USED BEFORE. THE CONSUMER REPORTED THAT THIS MORNING, WHEN SHE WAS BRUSHING HER TEETH SHE STARTED TO GAG. THE CONSUMER REPORTED THAT A SECTION OF BRISTLES HAD COME OFF THE BRUSH(PRODUCT COMPLAINT). THE CONSUMER STATED THAT SHE FELT THIS WAS A DANGEROUS PRODUCT AS IT COULD CAUSE CHOKING. (B)(4). FOLLOW-UP RECEIVED ON 28 NOVEMBER 2016 AND FINAL QA REPORT RECEIVED ON 07 DECEMBER 2016: IN (B)(6) 2016, THE PATIENT STARTED SENSODYNE PRONAMEL TOOTHBRUSH. IN (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING SENSODYNE PRONAMEL TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL INGESTION OF PRODUCT. SENSODYNE PRONAMEL TOOTHBRUSH WAS DISCONTINUED IN OCTOBER 2016 (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND ACCIDENTAL INGESTION OF PRODUCT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE PRONAMEL TOOTHBRUSH. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER VIA PHONE. THE CONSUMER REPORTED THAT SHE IS OVER 50 YEARS OLD. THE CONSUMER DID NOT HAVE THE LOT NUMBER OF THE TOOTHBRUSH. THE CONSUMER REPORTED THAT SHE STARTED USING THE TOOTHBRUSH THE LATER PART OF SEPTEMBER. THE CONSUMER REPORTED THAT SHE SWALLOWED THE BRISTLES AND HAD THE CHOKING THE WEEK BEFORE (B)(6) 2016. THE CONSUMER STOPPED USING THE PRODUCT THE WEEK BEFORE (B)(6) 2016. FINAL QA REPORT: THIS COMPLAINT WAS DEEMED UNSUBSTANTIATED.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF GAGGING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE PRONAMEL TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED SENSODYNE UNKNOWN, GSK TOOTHBRUSH (SENSODYNE TOOTHBRUSH), GSK TOOTHBRUSH (SENSODYNE SENSITIVE TOOTHBRUSH) AND POTASSIUM NITRATE, SODIUM FLUORIDE (SENSODYNE ULTRA FRESH). ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE PRONAMEL TOOTHBRUSH. ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING SENSODYNE PRONAMEL TOOTHBRUSH, THE PATIENT EXPERIENCED GAGGING AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE PRONAMEL TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE GAGGING WAS NOT REPORTED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE GAGGING TO BE RELATED TO SENSODYNE PRONAMEL 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, THE CONSUMER REPORTED THAT SHE HAD USED SENSODYNE(CONCOMITANT) FOR MANY YEARS AND HAD BEEN VERY SATISFIED WITH SENSODYNE TOOTHBRUSHES(CONCOMITANT) AS WELL. THE CONSUMER REPORTED THAT HER LAST TOOTHBRUSH PURCHASE WAS SENSODYNE PRONAMEL WHICH SHE HAD NEVER USED BEFORE. THE CONSUMER REPORTED THAT THIS MORNING, WHEN SHE WAS BRUSHING HER TEETH SHE STARTED TO GAG. THE CONSUMER REPORTED THAT A SECTION OF BRISTLES HAD COME OFF THE BRUSH(PRODUCT COMPLAINT). THE CONSUMER STATED THAT SHE FELT THIS WAS A DANGEROUS PRODUCT AS IT COULD CAUSE CHOKING. PRODUCT COMPLAINT NUMBER WAS (B)(4). FOLLOW-UP RECEIVED ON (B)(6) 2016 AND FINAL QA REPORT RECEIVED ON (B)(6) 2016: IN (B)(6) 2016, THE PATIENT STARTED SENSODYNE PRONAMEL TOOTHBRUSH. IN (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING SENSODYNE PRONAMEL TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL INGESTION OF PRODUCT. SENSODYNE PRONAMEL TOOTHBRUSH WAS DISCONTINUED IN (B)(6) 2016 (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND ACCIDENTAL INGESTION OF PRODUCT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE PRONAMEL TOOTHBRUSH. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER VIA PHONE. THE CONSUMER REPORTED THAT SHE IS OVER 50 YEARS OLD. THE CONSUMER DID NOT HAVE THE LOT NUMBER OF THE TOOTHBRUSH. THE CONSUMER REPORTED THAT SHE STARTED USING THE TOOTHBRUSH THE LATER PART OF (B)(6). THE CONSUMER REPORTED THAT SHE SWALLOWED THE BRISTLES AND HAD THE CHOKING THE WEEK BEFORE (B)(6) 2016. THE CONSUMER STOPPED USING THE PRODUCT THE WEEK BEFORE (B)(6)2016. FINAL QA REPORT: THIS COMPLAINT WAS DEEMED UNSUBSTANTIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832195 SENSODYNE PRONAMEL TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other