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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B DUALACTION OR DUAL CLEAN BRUSHHEADS; TOOTHBRUSH, POWERED
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BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B DUALACTION OR DUAL CLEAN BRUSHHEADS; TOOTHBRUSH, POWERED Back to Search Results
Model Number EB417-3
Device Problem Break (1069)
Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Tooth Fracture (2428); Foreign Body In Patient (2687)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Event Description
Cracking one of my teeth, broken tooth [tooth fracture].As i was brushing one of the brushes snapped out [device breakage].Brush snapped out and got stuck between lower jaw teeth [foreign body in mouth].A spontaneous report was received via e-mail on 18-jun-2020 from a consumer, unknown age and gender, stating that while brushing with an oral-b power rechargeable toothbrush handle professional care triumph on an unspecified date, one of the brushes on the oral-b dual clean brushhead snapped out and got stuck between the consumer's lower jaw teeth, cracking one of the teeth.The consumer had pieces of the broken tooth.The outcome of brush stuck between teeth was recovered.The outcome of broken tooth was unknown.The case outcome was improved.Treatment details: unknown.Relevant history: the consumer had used different types of oral-b brushes for the last 20 years.No further information was provided.
 
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Event Description
Cracking one of my teeth, broken tooth / #30 tooth chattered into pieces [tooth fracture], as i was brushing one of the brushes snapped out [device breakage], brush snapped out and got stuck between lower jaw teeth [foreign body in mouth] pain - tooth, inflammation - tooth [pulpitis dental], infection - tooth [tooth infection], abscess on #30 - tooth [tooth abscess], bleeding gum [gingival bleeding].Case description: a spontaneous report was received via e-mail on 18-jun-2020 from a consumer, unknown age and gender, stating that while brushing with an oral-b power rechargeable toothbrush handle professional care triumph on an unspecified date, one of the brushes on the oral-b dual clean brushhead snapped out and got stuck between the consumer's lower jaw teeth, cracking one of the teeth.The consumer had pieces of the broken tooth.The outcome of brush stuck between teeth was recovered.The outcome of broken tooth was unknown.The case outcome was improved.Treatment details: unknown.Relevant history: the consumer had used different types of oral-b brushes for the last 20 years.No further information was provided.On 03-aug-2020 received consumer's questionnaire: the consumer, a 62 year old male, used the oral-b triumph pro smart guide toothbrush with the dual action brush head for brushing teeth.He first used the product in (b)(6) 2020 and stopped using it on (b)(6) 2020.He had used the product for a couple of months/6 weeks before the problem with tooth #30 began and ended on (b)(6) 2020.The consumer explained that he had this incident where the dual clean brush head snapped off from the brush (the lower part that moves sideways not the round part).It got loose and stuck between his lower jaw teeth breaking tooth #30.The tooth chattered into pieces, causing pain, inflammation, and infection.He reported that no treatment was used for this problem but motrin was used for pain.He sought advice from the dentist/hygienist where he had an x-ray, evaluation, and prognosis.Antibiotic cephalexin 500mg was prescribed.An implant was recommended for tooth #30.The consumer reported that the prescribed/recommended treatment had been followed, but the problem had not resolved.The case outcome remained improved.Hist drug/prev exp: he had used the oral-b dual clean always for over 8 years; he had never experienced any issues with previous use.Concomitant product(s): crest pro-health advanced extra whitening rinse.Allergy/intolerance: none.No further information was provided.On 03-aug-2020 received dental records: (b)(6) 2020: abscess on #30 due to broken tooth while brushing with electric toothbrush.Tooth prognosis is guarded to very poor.Implant #30, extraction #30, implant, abutment.Patient treatment plan: ext erupt/exp root ram 30lr 1st molar, surgical place/impla ram 30lr 1st molar, abutment supp crown ram 30lr 1st molar, custom abutment ram 30lr.Medical history: cigarettes, pipe or cigar smoking; srp- 4 quads, 30 modl, b, 32 ol, 16 abscess at the apex, 9x9mm papilloma located on the labial mucosa adjacent to #28.Concomitant product(s): aspirin 81mg.No further information was provided.On 19-aug-2020 follow-up via phone: the consumer reported he was still in pain, and had not finished treatment.The overall case outcome remained improved.No further information was provided.On 15-sep-2020 received additional dental records: documentation from a (b)(6) 2017 appointment revealed the following additional medical history: moderate staining, moderate recession, moderate attrition, bone loss noted on x-rays, #30 do (disto-occlusal) filling broke off, abfraction #5.Patient received srp (scaling and root planning) and occlusal guard.No further information was provided.On 06-oct-2020 received second questionnaire: the consumer reported he also experienced light bleeding in the gum.The outcome was unknown.The case outcome remained improved.No further information was provided.On 17-nov-2020 product investigation results: no manufacturing cause identified based on investigation.
 
Event Description
Cracking one of my teeth, broken tooth / #30 tooth chattered into pieces [tooth fracture].As i was brushing one of the brushes snapped out [device breakage].Brush snapped out and got stuck between lower jaw teeth [foreign body in mouth].Pain - tooth [toothache].Inflammation - tooth [pulpitis dental].Infection - tooth [tooth infection].Abscess on #30 - tooth [tooth abscess].Case description: a spontaneous report was received via e-mail on 18-jun-2020 from a consumer, unknown age and gender, stating that while brushing with an oral-b power rechargeable toothbrush handle professional care triumph on an unspecified date, one of the brushes on the oral-b dual clean brushhead snapped out and got stuck between the consumer's lower jaw teeth, cracking one of the teeth.The consumer had pieces of the broken tooth.The outcome of brush stuck between teeth was recovered.The outcome of broken tooth was unknown.The case outcome was improved.Treatment details: unknown.Relevant history: the consumer had used different types of oral-b brushes for the last 20 years.No further information was provided.03-aug-2020 received consumer's questionnaire: the consumer, a 62 year old male, used the oral-b triumph pro smart guide toothbrush with the dual action brush head for brushing teeth.He first used the product in (b)(6) 2020 and stopped using it on (b)(6) 2020.He had used the product for a couple of months/6 weeks before the problem with tooth #30 began and ended on (b)(6) 2020.The consumer explained that he had this incident where the dual clean brush head snapped off from the brush (the lower part that moves sideways not the round part).It got loose and stuck between his lower jaw teeth breaking tooth #30.The tooth chattered into pieces, causing pain, inflammation, and infection.He reported that no treatment was used for this problem but motrin was used for pain.He sought advice from the dentist/hygienist where he had an x-ray, evaluation, and prognosis.Antibiotic cephalexin 500mg was prescribed.An implant was recommended for tooth #30.The consumer reported that the prescribed/recommended treatment had been followed, but the problem had not resolved.The case outcome remained improved.Hist drug/prev exp: he had used the oral-b dual clean always for over 8 years; he had never experienced any issues with previous use.Concomitant product(s): crest pro-health advanced extra whitening rinse.Allergy/intolerance: none.No further information was provided.03-aug-2020 received dental records: on (b)(6) 2020: abscess on #30 due to broken tooth while brushing with electric toothbrush.Tooth prognosis is guarded to very poor.Implant #30, extraction #30, implant, abutment.Patient treatment plan: ext erupt/exp root ram 30lr 1st molar, surgical place/impla ram 30lr 1st molar, abutment supp crown ram 30lr 1st molar, custom abutment ram 30lr.Medical history: cigarettes, pipe or cigar smoking; srp- 4 quads, 30 modl, b, 32 ol, 16 abscess at the apex, 9x9mm papilloma located on the labial mucosa adjacent to #28.Concomitant product(s): aspirin 81mg.No further information was provided.19-aug-2020 follow-up via phone: the consumer reported he was still in pain, and had not finished treatment.The overall case outcome remained improved.No further information was provided.
 
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Event Description
Cracking one of my teeth, broken tooth / #30 tooth chattered into pieces [tooth fracture].As i was brushing one of the brushes snapped out [device breakage].Brush snapped out and got stuck between lower jaw teeth [foreign body in mouth].Pain - tooth [toothache].Inflammation - tooth [pulpitis dental].Infection - tooth [tooth infection].Abscess on #30 - tooth [tooth abscess].A spontaneous report was received via e-mail on 18-jun-2020 from a consumer, unknown age and gender, stating that while brushing with an oral-b power rechargeable toothbrush handle professional care triumph on an unspecified date, one of the brushes on the oral-b dual clean brushhead snapped out and got stuck between the consumer's lower jaw teeth, cracking one of the teeth.The consumer had pieces of the broken tooth.The outcome of brush stuck between teeth was recovered.The outcome of broken tooth was unknown.The case outcome was improved.Treatment details: unknown.Relevant history: the consumer had used different types of oral-b brushes for the last 20 years.No further information was provided.03-aug-2020 received consumer's questionnaire: the consumer, a 62 year old male, used the oral-b triumph pro smart guide toothbrush with the dual action brush head for brushing teeth.He first used the product in (b)(6) 2020 and stopped using it on (b)(6) 2020.He had used the product for a couple of months/6 weeks before the problem with tooth #30 began and ended on (b)(6) 2020.The consumer explained that he had this incident where the dual clean brush head snapped off from the brush (the lower part that moves sideways not the round part).It got loose and stuck between his lower jaw teeth breaking tooth #30.The tooth chattered into pieces, causing pain, inflammation, and infection.He reported that no treatment was used for this problem but motrin was used for pain.He sought advice from the dentist/hygienist where he had an x-ray, evaluation, and prognosis.Antibiotic cephalexin 500mg was prescribed.An implant was recommended for tooth #30.The consumer reported that the prescribed/recommended treatment had been followed, but the problem had not resolved.The case outcome remained improved.Hist drug/prev exp: he had used the oral-b dual clean always for over 8 years; he had never experienced any issues with previous use.Concomitant product(s): crest pro-health advanced extra whitening rinse.Allergy/intolerance: none.No further information was provided.03-aug-2020 received dental records: (b)(6) 2020: abscess on #30 due to broken tooth while brushing with electric toothbrush.Tooth prognosis is guarded to very poor.Implant #30, extraction #30, implant, abutment.Patient treatment plan: ext erupt/exp root ram 30lr 1st molar, surgical place/impla ram 30lr 1st molar, abutment supp crown ram 30lr 1st molar, custom abutment ram 30lr.Medical history: cigarettes, pipe or cigar smoking; srp- 4 quads, 30 modl, b, 32 ol, 16 abscess at the apex, 9x9mm papilloma located on the labial mucosa adjacent to #28.Concomitant product(s): aspirin 81mg.No further information was provided.19-aug-2020 follow-up via phone: the consumer reported he was still in pain, and had not finished treatment.The overall case outcome remained improved.No further information was provided.15-sep-2020 received additional dental records: documentation from a (b)(6) 2017 appointment revealed the following additional medical history: moderate staining, moderate recession, moderate attrition, bone loss noted on x-rays, #30 do (disto-occlusal) filling broke off, abfraction #5.Patient received srp (scaling and root planning) and occlusal guard.No further information was provided.
 
Event Description
Cracking one of my teeth, broken tooth / #30 tooth shattered into pieces [tooth fracture].As i was brushing one of the brushes snapped out [device breakage].Brush snapped out and got stuck between lower jaw teeth [foreign body in mouth].Pain - tooth [toothache]; inflammation - tooth [pulpitis dental]; infection - tooth [tooth infection]; abscess on #30 - tooth [tooth abscess]; bleeding gum [gingival bleeding].Case description: a spontaneous report was received via e-mail on (b)(6)2020 from a consumer, unknown age and gender, stating that while brushing with an oral-b power rechargeable toothbrush handle professional care triumph on an unspecified date, one of the brushes on the oral-b dual clean brushhead snapped out and got stuck between the consumer's lower jaw teeth, cracking one of the teeth.The consumer had pieces of the broken tooth.The outcome of brush stuck between teeth was recovered.The outcome of broken tooth was unknown.The case outcome was improved.Treatment details: unknown.Relevant history: the consumer had used different types of oral-b brushes for the last 20 years.No further information was provided.On (b)(6) 2020 received consumer's questionnaire: the consumer, a 62 year old male, used the oral-b triumph pro smart guide toothbrush with the dual action brush head for brushing teeth.He first used the product in (b)(6) 2020 and stopped using it on (b)(6) 2020.He had used the product for a couple of months/6 weeks before the problem with tooth #30 began and ended on (b)(6) 2020.The consumer explained that he had this incident where the dual clean brush head snapped off from the brush (the lower part that moves sideways not the round part).It got loose and stuck between his lower jaw teeth breaking tooth #30.The tooth chattered into pieces, causing pain, inflammation, and infection.He reported that no treatment was used for this problem but motrin was used for pain.He sought advice from the dentist/hygienist where he had an x-ray, evaluation, and prognosis.Antibiotic cephalexin 500mg was prescribed.An implant was recommended for tooth #30.The consumer reported that the prescribed/recommended treatment had been followed, but the problem had not resolved.The case outcome remained improved.Hist drug/prev exp: he had used the oral-b dual clean always for over 8 years; he had never experienced any issues with previous use.Concomitant product(s): crest pro-health advanced extra whitening rinse.Allergy/intolerance: none.No further information was provided.On (b)(6) 2020 received dental records: on (b)(6) 2020: abscess on #30 due to broken tooth while brushing with electric toothbrush.Tooth prognosis is guarded to very poor.Implant #30, extraction #30, implant, abutment.Patient treatment plan: ext erupt/exp root ram 30lr 1st molar, surgical place/impla ram 30lr 1st molar, abutment supp crown ram 30lr 1st molar, custom abutment ram 30lr.Medical history: cigarettes, pipe or cigar smoking; srp- 4 quads, 30 modl, b, 32 ol, 16 abscess at the apex, 9x9mm papilloma located on the labial mucosa adjacent to #28.Concomitant product(s): aspirin 81mg.No further information was provided.On (b)(6) 2020 follow-up via phone: the consumer reported he was still in pain, and had not finished treatment.The overall case outcome remained improved.No further information was provided.On (b)(6) 2020 received additional dental records: documentation from a (b)(6) 2017 appointment revealed the following additional medical history: moderate staining, moderate recession, moderate attrition, bone loss noted on x-rays, #30 do (disto-occlusal) filling broke off, abfraction #5.Patient received srp (scaling and root planning) and occlusal guard.No further information was provided.On (b)(6) 2020 received second questionnaire: the consumer reported he also experienced light bleeding in the gum.The outcome was unknown.The case outcome remained improved.No further information was provided.
 
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
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Brand Name
ORAL-B DUALACTION OR DUAL CLEAN BRUSHHEADS
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
MDR Report Key10272794
MDR Text Key201854283
Report Number3000302531-2020-00122
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberEB417-3
Device Lot Number9056786000 OR 9264786000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/18/2020
Initial Date FDA Received07/14/2020
Supplement Dates Manufacturer Received08/03/2020
09/15/2020
09/15/2020
11/17/2020
Supplement Dates FDA Received08/25/2020
10/07/2020
10/21/2020
12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ASPIRIN / 00002701 (ACETYLSALICYLIC ACID); ASPIRIN / 00002701 (ACETYLSALICYLIC ACID); ASPIRIN /00002701; ASPIRIN /00002701/; CREST PRO-HEALTH ADVANCED EXTRA WHITENING RINSE; CREST PRO-HEALTH ADVANCED EXTRA WHITENING RINSE; CREST PRO-HEALTH ADVANCED EXTRA WHITENING RINSE; CREST PRO-HEALTH ADVANCED EXTRA WHITENING RINSE; ORAL-B POWER RCHRGBL TB HANDLE PRO CARE TRIUMPH; ORAL-B POWER RECHARGE TB HANDLE PROF CARE TRIUMPH; ORAL-B POWER RECHARGE TB HANDLE PROF CARE TRIUMPH; ORAL-B PWR RECHARGEABLE TB HANDLE PRO CARE TRIUMPH; ORAL-B PWR RECHARGEABLE TB HANDLE PRO CARE TRIUMPH
Patient Outcome(s) Other;
Patient Age62 YR
Patient Weight84
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