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

Model Number 3709

Device Problems Burst Container or Vessel (1074); Output Problem (3005)

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

Event Type  malfunction  

Event Description

Exploded - oral-b [device battery explosion].Liquid sprayed out of the toothbrush.Hand piece no longer works - oral-b [device breakage].Case narrative: male consumer via phone stated that liquid sprayed out of his three year old oral-b toothbrush, model 3709, at night.The hand piece did not work any longer and it basically exploded.No injury was reported.

Manufacturer Narrative

Product return was requested but not received so far.

Manufacturer Narrative

On 20-feb-2023 product investigation results: complained product received user handling was identified as root cause for the complaint.

Event Description

Exploded - oral-b [device battery explosion].Liquid sprayed out of the toothbrush.Hand piece no longer works - oral-b [device breakage].Case narrative: male consumer via phone stated that liquid sprayed out of his three year old oral-b toothbrush, model 3709, at night.The hand piece did not work any longer and it basically exploded.No injury was reported.On 31-jan-2023 amendment from information initially received on 16-jun-2022: the suspect product lot was r63921552.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 ma; son-montgomery rd; mason 45040
• MDR Report Key: 15014167
• MDR Text Key: 295957661
• Report Number: 3000302531-2022-00265
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• 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: R63921552
• 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
• Patient Sex: Male