MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3764PRO6500MODELD36.545.5HX; TOOTHBRUSH, POWERED - JEQ

Model Number D36.545.5HX

Device Problems Break (1069); Degraded (1153)

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

Event Type  malfunction  

Event Description

Brushheads no longer staying securely attached and keep falling off - oral-b [device breakage].Severe abrasion on the metal pin - oral-b [device physical property issue].Case narrative: female consumer via e-mail stated that their oral-b electric triumph professional care pro 6500 toothbrush had severe abrasion on the metal pin.The original oral-b toothbrush heads no longer stayed securely attached and kept falling off 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.

Manufacturer Narrative

01-sep-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 and plastic parts due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.

Event Description

Brushheads no longer staying securely attached and keep falling off - oral-b [device breakage] severe abrasion on the metal pin - oral-b [device physical property issue] case narrative: female consumer via e-mail stated that their oral-b electric triumph professional care pro 6500 toothbrush had severe abrasion on the metal pin.The original oral-b toothbrush heads no longer stayed securely attached and kept falling off mid-brushing.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3764PRO6500MODELD36.545.5HX
• 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: 15041543
• MDR Text Key: 303809640
• Report Number: 3000302531-2022-00271
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D36.545.5HX
• Device Lot Number: R 71920312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE.; ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE.
• Patient Sex: Female