MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765; TOOTHBRUSH, POWERED - JEQ

Model Number 3765

Device Problems Corroded (1131); Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

This report is being filed due to an alleged fire event.This report is being filled out of an abundance of caution.Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

Event Description

Starting to smoke.Inside part in which the head goes in is starting to rust - oral-b [device physical property issue].Case narrative: consumer via chat stated that their oral-b toothbrush, type 3765 (product lot: bc803191754) was starting to smoke and the inside part in which the toothbrush head went in was starting to rust.No injury was reported.

Manufacturer Narrative

03-aug-2022 product investigation results: product return was received and evaluated.No failure could be identified, the product is according to specifications.

Event Description

Starting to smoke.Inside part in which the head goes in is starting to rust - oral-b [device physical property issue].Case narrative: consumer via chat stated that their oral-b toothbrush, type 3765 (product lot: bc803191754) was starting to smoke and the inside part in which the toothbrush head went in was starting to rust.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765
• 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): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700; mason-montgomery rd; mason 45040
• MDR Report Key: 14619631
• MDR Text Key: 300125154
• Report Number: 3000302531-2022-00227
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3765
• Device Lot Number: BC803191754
• 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