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

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.

• 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 Key: 12268439
• MDR Text Key: 266847307
• Report Number: 3000302531-2021-00268
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• 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 Number: D34.555.6X
• Device Lot Number: R42051420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 11/08/2021
• 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 Number: 1
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN; ORAL-B PWR/RECHARGEABLE TB HND/3765/GENIUS/10000N; ORALBPWRRCHGTBHDL3762TRIUMPHTRIZONEMODELD34.555.6X
• Patient Sex: Female