BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSODYNE PRONAMEL SOFT TOOTHBRUSH

    MDR report key: 6858344 · Received September 12, 2017

    Report

    Report Number
    9615008-2017-00014
    Event Type
    Injury
    Date Received
    September 12, 2017
    Report Date
    August 29, 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
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT # 9615008-2017-00014 IS ASSOCIATED WITH (B)(4), SENSODYNE PRONAMEL SOFT TOOTHBRUSH. SENSODYNE PRONAMEL SOFT TOOTHBRUSH IS MARKETED AS SENSODYNE PRONAMEL TOOTHBRUSH IN THE U.S.

    Additional Manufacturer Narrative · 1

    9615008-2017-00014 IS ASSOCIATED WITH ARGUS ID (B)(4), SENSODYNE PRONAMEL SOFT TOOTHBRUSH. SENSODYNE PRONAMEL SOFT TOOTHBRUSH IS MARKETED AS SENSODYNE PRONAMEL TOOTHBRUSH IN THE US.

    Additional Manufacturer Narrative · 1

    9615008-2017-00014 IS ASSOCIATED WITH ARGUS ID (B)(4), SENSODYNE PRONAMEL SOFT TOOTHBRUSH. SENSODYNE PRONAMEL SOFT TOOTHBRUSH IS MARKETED AS SENSODYNE PRONAMEL TOOTHBRUSH IN THE US. DEVICE EVALUATION ON 23 OCTOBER 2017 REASON FOR COMPLAINT WAS MISSING/ FALLEN OUT TUFT(S). INVESTIGATION CONCLUSION FOUND THAT AFTER THE INCREASING RETURNS FROM THE (B)(4) MARKET AN INVESTIGATION WAS STARTED WITH THE OUTCOME THAT THIS ALTERNATIVE MATERIAL, MANUFACTURED WITH TOO LOW TEMPERATURE ADJUSTMENTS, WAS THE ROOT CAUSE FOR THESE COMPLAINTS. IT WAS DECIDED TOGETHER WITH GSK NOT MORE TO USE THIS ALTERNATIVE MATERIAL AND TO REMOVE IT FROM SPECIFICATIONS. CORRECTIVE ACTIONS: MATERIAL WAS CHANGED BACK IN DECEMBER (08.12.2016) TO MOPLEN EP 548S WITH CORRECT MOULDING TEMPERATURE. THE COMPLAINT WAS CONSIDERED SUBSTANTIATED. THE DETECTED DEFECT IS A MANUFACTURING ERROR.

    Additional Manufacturer Narrative · 1

    9615008-2017-00014 IS ASSOCIATED WITH ARGUS ID (B)(4), SENSODYNE PRONAMEL SOFT TOOTHBRUSH. SENSODYNE PRONAMEL SOFT TOOTHBRUSH IS MARKETED AS SENSODYNE PRONAMEL TOOTHBRUSH IN THE US. DEVICE EVALUATION ON 23 OCTOBER 2017 REASON FOR COMPLAINT WAS MISSING/ FALLEN OUT TUFT(S). INVESTIGATION CONCLUSION FOUND THAT AFTER THE INCREASING RETURNS FROM THE UK MARKET AN INVESTIGATION WAS STARTED WITH THE OUTCOME THAT THIS ALTERNATIVE MATERIAL, MANUFACTURED WITH TOO LOW TEMPERATURE ADJUSTMENTS, WAS THE ROOT CAUSE FOR THESE COMPLAINTS. IT WAS DECIDED TOGETHER WITH GSK NOT MORE TO USE THIS ALTERNATIVE MATERIAL AND TO REMOVE IT FROM SPECIFICATIONS. CORRECTIVE ACTIONS: MATERIAL WAS CHANGED BACK IN DECEMBER (08.12.2016) TO MOPLEN EP 548S WITH CORRECT MOULDING TEMPERATURE. THE COMPLAINT WAS CONSIDERED SUBSTANTIATED. THE DETECTED DEFECT IS A MANUFACTURING ERROR. FU3: FOLLOW-UP 2 WAS SUBMITTED ON 01 NOVEMBER 2017 AND FAILED TO HAVE THE QA RESULTS ATTACHED. FOLLOW-UP 3 WAS GENERATED TO INCLUDE THE QA RESULTS. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    NEARLY CHOKED [CHOKING]. 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 (SENSODYNE PRONAMEL SOFT TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE PRONAMEL SOFT TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE PRONAMEL SOFT TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE PRONAMEL SOFT TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE PRONAMEL SOFT TOOTHBRUSH. ADDITIONAL DETAILS: THE PATIENT PURCHASED A SENSODYNE PRONAMEL SOFT TOOTHBRUSH AND THE FIRST TIME SHE BRUSHED HER TEETH WITH IT ONE OF THE BUNCHES OF BRISTLES FELL OUT AND SHE NEARLY CHOKED ON IT. SHE USED THE BRUSH FOR A SECOND TIME AND A FEW MORE OF THE BRISTLES FELT OUT. SHE WAS RAISING THIS ISSUE WITH YOU AS SHE WAS NOT SURE WHY THIS HAPPENED AND IN CASE, IT HAPPENED TO SOMEONE ELSE WITH A DIFFERENT OUTCOME. IT MIGHT JUST BE A PROBLEM WITH THIS BATCH OF BRUSHED AS SHE HAD USED THIS TYPE OF BRUSH BEFORE. THIS CASE WAS ORIGINALLY ROUTED UNDER CASE NUMBER: (B)(4). THIS CASE WAS ROUTED ON 01 SEP 2017.

    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 FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE PRONAMEL SOFT TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE PRONAMEL SOFT TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE PRONAMEL SOFT TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE PRONAMEL SOFT TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE PRONAMEL SOFT TOOTHBRUSH. ADDITIONAL DETAILS: THE PATIENT PURCHASED A SENSODYNE PRONAMEL SOFT TOOTHBRUSH AND THE FIRST TIME SHE BRUSHED HER TEETH WITH IT ONE OF THE BUNCHES OF BRISTLES FELL OUT AND SHE NEARLY CHOKED ON IT. SHE USED THE BRUSH FOR A SECOND TIME AND A FEW MORE OF THE BRISTLES FELT OUT. SHE WAS RAISING THIS ISSUE WITH YOU AS SHE WAS NOT SURE WHY THIS HAPPENED AND IN CASE IT HAPPENED TO SOMEONE ELSE WITH A DIFFERENT OUTCOME. IT MIGHT JUST BE A PROBLEM WITH THIS BATCH OF BRUSHED AS SHE HAD USED THIS TYPE OF BRUSH BEFORE. THIS CASE WAS ORIGINALLY ROUTED UNDER CASE NUMBER: (B)(4). THIS CASE WAS ROUTED ON 01 SEP 2017. FOLLOW UP RECEIVED ON 26-SEP-2017: THE BATCH NUMBER HAS BEEN UPDATED.

    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 FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (SENSODYNE PRONAMEL SOFT TOOTHBRUSH) TOOTHBRUSH FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED SENSODYNE PRONAMEL SOFT TOOTHBRUSH AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SENSODYNE PRONAMEL SOFT TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH SENSODYNE PRONAMEL SOFT TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SENSODYNE PRONAMEL SOFT TOOTHBRUSH. ADDITIONAL DETAILS: THE PATIENT PURCHASED A SENSODYNE PRONAMEL SOFT TOOTHBRUSH AND THE FIRST TIME SHE BRUSHED HER TEETH WITH IT ONE OF THE BUNCHES OF BRISTLES FELL OUT AND SHE NEARLY CHOKED ON IT. SHE USED THE BRUSH FOR A SECOND TIME AND A FEW MORE OF THE BRISTLES FELT OUT. SHE WAS RAISING THIS ISSUE WITH YOU AS SHE WAS NOT SURE WHY THIS HAPPENED AND IN CASE IT HAPPENED TO SOMEONE ELSE WITH A DIFFERENT OUTCOME. IT MIGHT JUST BE A PROBLEM WITH THIS BATCH OF BRUSHED AS SHE HAD USED THIS TYPE OF BRUSH BEFORE. THIS CASE WAS ORIGINALLY ROUTED UNDER CASE NUMBER: (B)(4). THIS CASE WAS ROUTED ON 01 SEP 2017. FOLLOW UP RECEIVED ON 26-SEP-2017: THE BATCH NUMBER HAS BEEN UPDATED FOLLOW UP INFORMATION RECEIVED 23 OCTOBER 2017. ROOT CAUSE ANALYSIS: NO DEVIATIONS WERE RECORDED DURING PRODUCTION OF THE CLAIMED TOOTHBRUSH. THERE WERE TWO KIND OF PP MATERIALS APPROVED AND LISTED IN THE SPECIFICATION. (MULTI SUPPLY SOURCE) IN THE STATED PERIOD (11/8/2016-12/8/2016) THE ALTERNATIVE MATERIAL WAS USED IN PRODUCTION, WHAT IS NOT AN ISSUE ITSELF. BUT AFTER THE INCREASING RETURNS FROM THE (B)(4) MARKET AN INVESTIGATION WAS STARTED WITH THE OUTCOME THAT THIS ALTERNATIVE MATERIAL, MANUFACTURED WITH TOO LOW TEMPERATURE ADJUSTMENTS, WAS THE ROOT CAUSE FOR THESE COMPLAINTS. IT WAS DECIDED TOGETHER WITH GSK NOT MORE TO USE THIS ALTERNATIVE MATERIAL AND TO REMOVE IT FROM SPECIFICATIONS. CORRECTIVE ACTIONS: MATERIAL WAS CHANGED BACK IN DECEMBER (08.12.2016) TO MOPLEN EP 548S WITH CORRECT MOULDING TEMPERATURE. THE COMPLAINT WAS CONSIDERED SUBSTANTIATED. THE DETECTED DEFECT IS A MANUFACTURING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638661 SENSODYNE PRONAMEL SOFT TOOTHBRUSH TOOTHBRUSHES EFW M + C SCHIFFER GMBH 71433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other