MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3764; TOOTHBRUSH, POWERED - JEQ

Model Number 3764

Device Problems Loose or Intermittent Connection (1371); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Brush heads no longer stay attached securely to the hand piece and come loose - oral-b [device connection issue].Metal pin on toothbrush hand pieces becomes worn down - oral-b [device physical property issue].Case narrative: male consumer via e-mail stated that the metal pin on his oral-b pro 600 smart series toothbrush hand piece (type 3764) became worn down.The oral-b trizone eb30 toothbrush heads no longer stayed securely attached and came loose from the oral-b hand piece mid-brushing.No injury was reported.

Manufacturer Narrative

Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

Event Description

Brush heads no longer stay attached securely to the hand piece and come loose - oral-b [device connection issue].Metal pin on toothbrush hand pieces becomes worn down - oral-b [device physical property issue].Case narrative: male consumer via e-mail stated that the metal pin on his oral-b pro 600 smart series toothbrush hand piece (type 3764) became worn down.The oral-b trizone eb30 toothbrush heads no longer stayed securely attached and came loose from the oral-b hand piece mid-brushing.No injury was reported.

Manufacturer Narrative

23-aug-2022 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.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3764
• Type of Device: TOOTHBRUSH, POWERED - JEQ
• 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: mgr. affairs, oral care-see co ; mason business center 8700; mason-montgomery rd; mason 45040
• MDR Report Key: 14653782
• MDR Text Key: 301201774
• Report Number: 3000302531-2022-00236
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• 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: 09/11/2022

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: 3764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/12/2022
• 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: ORALBPWRPWRORALCARERFLSTRIZONEEB30 (ORAL-B POWER/P).; ORALBPWRPWRORALCARERFLSTRIZONEEB30 (ORAL-B POWER/P).
• Patient Sex: Male