MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3709; TOOTHBRUSH, POWERED - JEQ

Model Number 3709

Device Problem Sparking (2595)

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

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

Oral-b toothbrush sparked [device physical property issue].Case narrative: consumer via e-mail stated that their oral-b toothbrush sparked in the middle of the night last night (in (b)(6) 2022).No injury was reported.

Manufacturer Narrative

20-oct-2022, product investigation results: product return was received and investigated.Product investigation results showed that the complaint is due to a breakage of the mains cable followed by electrical arcing from the mains voltage caused by an effect of force , which is related to user handling.

Event Description

Oral-b toothbrush sparked [device physical property issue].Electric toothbrush exploded - oral-b [device battery explosion].Case narrative: consumer via e-mail stated that their oral-b toothbrush sparked in the middle of the night last night (on (b)(6) 2022).No injury was reported.12-jul-2022 follow up via chat: the consumer reported that the oral-b electric toothbrush exploded.No injury was reported.24-jul-2022 follow up via image: the suspect product lot was n2820.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3709
• 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: 15140462
• MDR Text Key: 304186739
• Report Number: 3000302531-2022-00290
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

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: 3709
• Device Lot Number: N2820
• 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: 08/01/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2022
• 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