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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3762TRIUMPHTRIZONEMODELD34.555.6X; TOOTHBRUSH, POWERED

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3762TRIUMPHTRIZONEMODELD34.555.6X; TOOTHBRUSH, POWERED Back to Search Results
Model Number D34.555.6X
Device Problems Break (1069); Loose or Intermittent Connection (1371); Separation Problem (4043)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  malfunction  
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Event Description
Injuries - mouth [mouth injury].Brush heads come loose from the hand piece - oral-b [device connection issue].Brush heads constantly come off - oral-b [device breakage].Female consumer via e-mail stated that the oral-b brush heads came loose from the oral-b hand pieces very easily, even while brushing, which resulted in bad injuries.No serious injury was reported.23-jul-2021 follow up via e-mail: the consumer stated that the brush heads constantly came off.No serious injury was reported.
 
Manufacturer Narrative
13-oct-2021 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by wear of the driving shaft due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.
 
Event Description
Injuries - mouth [mouth injury].Brush heads come loose from the hand piece - oral-b [device connection issue].Brush heads constantly come off - oral-b [device breakage].Female consumer via e-mail stated that the oral-b brush heads came loose from the oral-b hand pieces very easily, even while brushing, which resulted in bad injuries.No serious injury was reported.23-jul-2021 follow up via e-mail: the consumer stated that the brush heads constantly came off.No serious injury was reported.13-oct-2021 case updated: suspect product updated to oral-b power rechargeable toothbrush handle 3762 triumph trizone model d34.555.6x.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE3762TRIUMPHTRIZONEMODELD34.555.6X
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
Manufacturer (Section G)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM   D-97828
Manufacturer Contact
regulatory oral care
8700 mason-montgomery rd
mason, OH 45040
MDR Report Key12268439
MDR Text Key266847307
Report Number3000302531-2021-00268
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberD34.555.6X
Device Lot NumberR42051420
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/21/2021
Initial Date FDA Received08/03/2021
Supplement Dates Manufacturer Received10/13/2021
Supplement Dates FDA Received11/08/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ORAL-B BRUSHHEADS, VERSION UNKNOWN; ORAL-B PWR/RECHARGEABLE TB HND/3765/GENIUS/10000N; ORALBPWRRCHGTBHDL3762TRIUMPHTRIZONEMODELD34.555.6X
Patient SexFemale
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