MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3766PRO2900MODELD501.523.2H; TOOTHBRUSH, POWERED - JEQ

Model Number D501.523.2H

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

Poked in cheek with the metal pin - mouth [mouth injury] no longer stay attached.Brush head had fallen off - oral-b [device breakage] brush heads have kept getting increasingly more loose-fitting - oral-b [device connection issue].Metal pin thin.Metal can become this worn down - oral-b [device physical property issue].Case narrative: consumer via e-mail stated that the oral-b toothbrush heads got increasingly loose-fitting on the oral-b toothbrush 1000 series (pro 2 2900) and no longer stayed attached at all, resulting in the consumer being poked in the cheek with the metal pin during brushing after the brush head fell off.No serious 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

15-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 materials due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.

Event Description

Poked in cheek with the metal pin - mouth [mouth injury].No longer stay attached.Brush head had fallen off - oral-b [device breakage].Brush heads have kept getting increasingly more loose-fitting - oral-b [device connection issue].Metal pin thin.Metal can become this worn down - oral-b [device physical property issue].Case narrative: consumer via e-mail stated that the oral-b toothbrush heads got increasingly loose-fitting on the oral-b toothbrush 1000 series (pro 2 2900) and no longer stayed attached at all, resulting in the consumer being poked in the cheek with the metal pin during brushing after the brush head fell off.No serious injury was reported.26-jul-2022 case update: the suspect product lot was 2ab91321958.No serious injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3766PRO2900MODELD501.523.2H
• 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: 14631653
• MDR Text Key: 301350601
• Report Number: 3000302531-2022-00230
• 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: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D501.523.2H
• Device Lot Number: 2AB91321958
• 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 (ALL OTHER NON-; ORAL-B BRUSHHEADS, VERSION UNKNOWN (ALL OTHER NON-