BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORALBPWRRCHGTOOTHBRUSHHANDLETRIUMPH3762MODELD34.565.5X

    MDR report key: 6139357 · Received December 1, 2016

    Report

    Report Number
    3000302531-2016-00474
    Event Type
    Injury
    Date Received
    December 1, 2016
    Report Date
    November 1, 2016
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT HAS BEEN REQUESTED. PRODUCT AND LOT NUMBER NOT PROVIDED BY REPORTER THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT HAS BEEN REQUESTED. PRODUCT AND LOT NUMBER NOT PROVIDED BY REPORTER THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT HAS BEEN REQUESTED. PRODUCT AND LOT NUMBER NOT PROVIDED BY REPORTER THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.

    Description of Event or Problem · 1

    PAIN, HURT - TOOTH; TOOTH ACHE [TOOTHACHE]. OVERSENSITIVITY IN TEETH [SENSITIVITY OF TEETH]. IRRITATED - TOOTH [DENTAL DISCOMFORT]. TEETH DO NOT DO WELL WITH THAT KIND OF VIBRATION AND ARE CONSTANTLY IRRITATED BY IT [INJURY ASSOCIATED WITH DEVICE]. ON (B)(6) 2016: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA LETTER DATED (B)(6) 2016 THAT SHE PURCHASED AN ORAL-B WHITE 6000 POWER RECHARGEABLE TOOTHBRUSH AND USED THE TOOTHBRUSH FOR TWO WEEKS ON AN UNSPECIFIED DATE. THE CONSUMER ASSERTED HER TEETH BEGAN TO HURT AFTER JUST THE SECOND DAY OF PRODUCT USE. ALL OF HER TEETH WERE AFFECTED BY THIS, AS THEY WERE EXTREMELY SENSITIVE TO PRESSURE, COLD, HEAT, SWEETS, AND EATING WAS DIFFICULT SO SHE STOPPED USING THE TOOTHBRUSH. THE OVERSENSITIVITY OF HER TEETH ABATED AFTER A FEW DAYS, WITH THE EXCEPTION OF ONE MOLAR THAT REFUSED TO CALM DOWN. BECAUSE THE TOOTH PAIN BECAME MORE INTOLERABLE OVER THE WEEKS AND DID NOT IMPROVE, SHE VISITED HER DENTIST. TREATMENT INCLUDED A ROOT CANAL. THE CONSUMER CLARIFIED THAT HER TEETH DO NOT DO WELL WITH THIS KIND OF VIBRATION AND SEEM TO BE CONSTANTLY IRRITATED BY THE TOOTHBRUSH SO PRODUCT USE WAS DISCONTINUED AND THE CONSUMER PLANNED TO STICK WITH THE OLD METHOD. THE CONSUMER REQUESTED TO RETURN THE PRODUCT IN ORDER TO RECEIVE A REFUND FOR THE PURCHASE. THE CASE OUTCOME WAS IMPROVED. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT(S): NONE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2017 RECEIVED CONSUMER'S COMPLETED MEDICAL QUESTIONNAIRE, LETTER, RECEIPTS (TRANSLATION OF DOCUMENTS RECEIVED (B)(6) 2017). THE (B)(6) FEMALE CONSUMER BEGAN USING THE ORAL-B WHITE 6000 POWER RECHARGEABLE TOOTHBRUSH IN (B)(6) 2016 AND STOPPED USING THE TOOTHBRUSH 1-2 WEEKS LATER IN 2016. SHE USED THE TOOTHBRUSH TWICE DAILY IN THE MORNING AND EVENING AND AFTER APPROXIMATELY TWO DAYS EXPERIENCED A TOOTHACHE AND ALL TEETH WERE AFFECTED IN 2016. PRODUCT USE WAS DISCONTINUED. SHE ASSERTED THAT A DENTIST WAS VISITED, AND THE DENTIST PERFORMED A ROOT CANAL PROCEDURE UNDER ANESTHESIA. WHILE HER SYMPTOMS HAD IMPROVED, THEY HAD STILL LINGERED. RELEVANT MEDICAL HISTORY: ALLERGIES: NO ALLERGIES; THE CONSUMER DID NOT SUFFER FROM ASTHMA, HAY FEVER OR RASH. CONCOMITANT MEDICATION(S): NONE. THE CASE OUTCOME REMAINED IMPROVED. EXACT PRODUCT USED PREVIOUSLY: NO. NO FURTHER INFORMATION WAS PROVIDED. CONSUMER'S FOLLOW-UP LETTER DATED 23-JAN-2017. THE CONSUMER EXPLAINED THAT SHE HAD USED AN ORAL-B WHITE 6000 POWER RECHARGEABLE TOOTHBRUSH WHICH RESULTED IN A SEVERE TOOTHACHE. SHE DESCRIBED ONE TOOTH THAT COULD NOT BE DESENSITIZED AND A ROOT CANAL TREATMENT WAS PERFORMED. THE CONSUMER ATTACHED HER QUESTIONNAIRE, COPY OF THE INVOICE OF THE DENTIST, AS WELL AS PURCHASE RECEIPT OF HER INITIAL LETTER DATED (B)(6) 2016. NO FURTHER INFORMATION WAS PROVIDED. DENTAL INVOICE OF SERVICES (AND COSTS FOR EXPENSES): ON (B)(6) 2016: INTRAORAL CONDUCTIVE ANESTHESIA; ANESTHETIC; TREPANATION OF A TOOTH; TEMPORARY SALIVA TIGHT CLOSURE OF CAVITY (B)(6) 2016: INTRAORAL CONDUCTIVE ANESTHESIA; ANESTHETIC; X-RAY TEETH; PREPARATION OF A ROOT CANAL, INCLUDING RETROGRADE PER CANAL, PERHAPS IN SEVERAL SESSIONS; TEMPORARY SALIVA TIGHT CLOSURE OF A CAVITY (B)(6) 2016: X-RAY TEETH; ELECTROMETRIC DETERMINATION OF THE LENGTH OF THE ROOT CANAL; ADDITIONAL APPLICATION OF ELECTROPHYSICAL CHEMICAL METHODS PER CANAL; FILLING OF A ROOT CANAL; SPECIAL MEASURES FOR PREPARING OR FILLING CAVITY; PREPARATION OF A CAVITY AND RESTORATION WITH COMPOSITE MATERIALS USING ADHESIVE TECHNOLOGY, SINGLE SURFACE, PERHAPS INCLUDING MULTI-LAYER TECHNOLOGY, INCLUDING POLISHING, PERHAPS INCLUDING USE OF INSERTS. ON (B)(6) 2017 CONSUMER'S FOLLOW-UP LETTER AND COINCIDING CONSUMER RELATIONS DEPARTMENT CONSUMER FOLLOW-UP ON 04-SEP-2017. THE CONSUMER INQUIRED ABOUT THE STATUS OF THE CASE. THE CONSUMER UNDERSTOOD THAT HER TASK WAS TO RETURN THE TOOTHBRUSH AND BE REFUNDED FOR ITS PURCHASE PRICE. SHE DID NOT WANT TO USE THE TOOTHBRUSH UNDER ANY CIRCUMSTANCES BECAUSE IT HAD CAUSED HER TO EXPERIENCE SERIOUS TOOTH ACHE/PAIN. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2017 RECEIVED CONSUMER FOLLOW-UP: THE CONSUMER REPORTED THAT SHE STILL HAD THE PURCHASE RECEIPT. SHE EXPLAINED THAT THE TOOTH ON WHICH SHE HAD TO HAVE A ROOT CANAL HAD TO BE PULLED NOW. THE CASE OUTCOME REMAINED IMPROVED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PAIN, HURT - TOOTH [TOOTHACHE]; OVERSENSITIVITY IN TEETH [SENSITIVITY OF TEETH]; IRRITATED - TOOTH [DENTAL DISCOMFORT]; TEETH DO NOT DO WELL WITH THAT KIND OF VIBRATION AND ARE CONSTANTLY IRRITATED BY IT [INJURY ASSOCIATED WITH DEVICE]. CASE DESCRIPTION: ON 01-NOV-2016: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA LETTER DATED 19-SEP-2016 THAT SHE PURCHASED AN ORAL-B WHITE 6000 POWER RECHARGEABLE TOOTHBRUSH AND USED THE TOOTHBRUSH FOR TWO WEEKS ON AN UNSPECIFIED DATE. THE CONSUMER ASSERTED HER TEETH BEGAN TO HURT AFTER JUST THE SECOND DAY OF PRODUCT USE. ALL OF HER TEETH WERE AFFECTED BY THIS, AS THEY WERE EXTREMELY SENSITIVE TO PRESSURE, COLD, HEAT, SWEETS, AND EATING WAS DIFFICULT SO SHE STOPPED USING THE TOOTHBRUSH. THE OVERSENSITIVITY OF HER TEETH ABATED AFTER A FEW DAYS, WITH THE EXCEPTION OF ONE MOLAR THAT REFUSED TO CALM DOWN. BECAUSE THE TOOTH PAIN BECAME MORE INTOLERABLE OVER THE WEEKS AND DID NOT IMPROVE, SHE VISITED HER DENTIST. TREATMENT INCLUDED A ROOT CANAL. THE CONSUMER CLARIFIED THAT HER TEETH DO NOT DO WELL WITH THIS KIND OF VIBRATION AND SEEM TO BE CONSTANTLY IRRITATED BY THE TOOTHBRUSH SO PRODUCT USE WAS DISCONTINUED AND THE CONSUMER PLANNED TO STICK WITH THE OLD METHOD. THE CONSUMER REQUESTED TO RETURN THE PRODUCT IN ORDER TO RECEIVE A REFUND FOR THE PURCHASE. THE CASE OUTCOME WAS IMPROVED. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT(S): NONE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PAIN, HURT - TOOTH [TOOTHACHE]; OVERSENSITIVITY IN TEETH [SENSITIVITY OF TEETH]; IRRITATED - TOOTH [DENTAL DISCOMFORT]; TEETH DO NOT DO WELL WITH THAT KIND OF VIBRATION AND ARE CONSTANTLY IRRITATED BY IT [INJURY ASSOCIATED WITH DEVICE]. CASE DESCRIPTION: ON 01-NOV-2016: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA LETTER DATED 19-SEP-2016 THAT SHE PURCHASED AN ORAL-B WHITE 6000 POWER RECHARGEABLE TOOTHBRUSH AND USED THE TOOTHBRUSH FOR TWO WEEKS ON AN UNSPECIFIED DATE. THE CONSUMER ASSERTED HER TEETH BEGAN TO HURT AFTER JUST THE SECOND DAY OF PRODUCT USE. ALL OF HER TEETH WERE AFFECTED BY THIS, AS THEY WERE EXTREMELY SENSITIVE TO PRESSURE, COLD, HEAT, SWEETS, AND EATING WAS DIFFICULT SO SHE STOPPED USING THE TOOTHBRUSH. THE OVERSENSITIVITY OF HER TEETH ABATED AFTER A FEW DAYS, WITH THE EXCEPTION OF ONE MOLAR THAT REFUSED TO CALM DOWN. BECAUSE THE TOOTH PAIN BECAME MORE INTOLERABLE OVER THE WEEKS AND DID NOT IMPROVE, SHE VISITED HER DENTIST. TREATMENT INCLUDED A ROOT CANAL. THE CONSUMER CLARIFIED THAT HER TEETH DO NOT DO WELL WITH THIS KIND OF VIBRATION AND SEEM TO BE CONSTANTLY IRRITATED BY THE TOOTHBRUSH SO PRODUCT USE WAS DISCONTINUED AND THE CONSUMER PLANNED TO STICK WITH THE OLD METHOD. THE CONSUMER REQUESTED TO RETURN THE PRODUCT IN ORDER TO RECEIVE A REFUND FOR THE PURCHASE. THE CASE OUTCOME WAS IMPROVED. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT(S): NONE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON 09-FEB-2017 RECEIVED CONSUMER'S COMPLETED MEDICAL QUESTIONNAIRE, LETTER, RECEIPTS (TRANSLATION OF DOCUMENTS RECEIVED 14-FEB-2017): MEDICAL QUESTIONNAIRE: THE (B)(6) FEMALE CONSUMER BEGAN USING THE ORAL-B SMART SERIES WHITE 6000 TOOTHBRUSH IN (B)(6) 2016 AND STOPPED USING THE TOOTHBRUSH 1-2 WEEKS LATER IN 2016. SHE USED THE TOOTHBRUSH TWICE DAILY IN THE MORNING AND EVENING AND AFTER APPROXIMATELY TWO DAYS EXPERIENCED A TOOTHACHE AND ALL TEETH WERE AFFECTED IN 2016. PRODUCT USE WAS DISCONTINUED. SHE ASSERTED THAT A DENTIST WAS VISITED, AND THE DENTIST PERFORMED A ROOT CANAL PROCEDURE UNDER ANESTHESIA. WHILE HER SYMPTOMS HAD IMPROVED, THEY HAD STILL LINGERED. RELEVANT MEDICAL HISTORY: ALLERGIES: NO ALLERGIES; THE CONSUMER DID NOT SUFFER FROM ASTHMA, HAY FEVER OR RASH. CONCOMITANT MEDICATION(S): NONE. THE CASE OUTCOME REMAINED IMPROVED. EXACT PRODUCT USED PREVIOUSLY: NO. NO FURTHER INFORMATION WAS PROVIDED. CONSUMER'S FOLLOW-UP LETTER DATED 23-JAN-2017: THE CONSUMER EXPLAINED THAT SHE HAD USED AN ORAL-B WHITE 6000 ELECTRIC TOOTHBRUSH WHICH RESULTED IN A SEVERE TOOTHACHE. SHE DESCRIBED ONE TOOTH THAT COULD NOT BE DESENSITIZED AND A ROOT CANAL TREATMENT WAS PERFORMED. THE CONSUMER ATTACHED HER QUESTIONNAIRE, COPY OF THE INVOICE OF THE DENTIST, AS WELL AS PURCHASE RECEIPT OF HER INITIAL LETTER DATED 19-SEP-2016. NO FURTHER INFORMATION WAS PROVIDED. DENTAL INVOICE OF SERVICES (AND COSTS FOR EXPENSES): ON (B)(6) 2016: INTRAORAL CONDUCTIVE ANESTHESIA; ANESTHETIC; TREPANATION OF A TOOTH; TEMPORARY SALIVA TIGHT CLOSURE OF CAVITY; ON (B)(6) 2016: INTRAORAL CONDUCTIVE ANESTHESIA; ANESTHETIC; X-RAY TEETH; PREPARATION OF A ROOT CANAL, INCLUDING RETROGRADE PER CANAL, PERHAPS IN SEVERAL SESSIONS; TEMPORARY SALIVA TIGHT CLOSURE OF A CAVITY; ON (B)(6) 2016: X-RAY TEETH; ELECTROMETRIC DETERMINATION OF THE LENGTH OF THE ROOT CANAL; ADDITIONAL APPLICATION OF ELECTROPHYSICAL CHEMICAL METHODS PER CANAL; FILLING OF A ROOT CANAL; SPECIAL MEASURES FOR PREPARING OR FILLING CAVITY; PREPARATION OF A CAVITY AND RESTORATION WITH COMPOSITE MATERIALS USING ADHESIVE TECHNOLOGY, SINGLE SURFACE, PERHAPS INCLUDING MULTI-LAYER TECHNOLOGY, INCLUDING POLISHING, PERHAPS INCLUDING USE OF INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788516 ORALBPWRRCHGTOOTHBRUSHHANDLETRIUMPH3762MODELD34.565.5X TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other