MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3754PROCROSSACTN5800MODELD21.535.4X; TOOTHBRUSH, POWERED - JEQ

Model Number D21.535.4X

Device Problems Fire (1245); Device Emits Odor (1425)

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

Smell of burning and discovered that the charging cable had burned out and charred the cable and the charging unit - oral-b [device catching fire].Case narrative: consumer via e-mail stated that last week ((b)(6) 2022) they awoke to a smell of burning and discovered that the charging cable had burned out, charring the cable and the charging unit.No injury was reported.11-oct-2022 follow up via image: the suspect product lot was aa54912117.No injury was reported.

Event Description

Smell of burning and discovered that the charging cable had burned out and charred the cable and the charging unit - oral-b [device catching fire] case narrative: consumer via e-mail stated that last week ((b)(6) 2022) they awoke to a smell of burning and discovered that the charging cable had burned out, charring the cable and the charging unit.No injury was reported.11-oct-2022 follow up via image: the suspect product lot was aa54912117.No injury was reported.

Manufacturer Narrative

07-dec-2022 product investigation results: product return was received and investigated.Product investigation results showed that complaint was caused by a breakage of the mains cable due to improper consumer handling.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3754PROCROSSACTN5800MODELD21.535.4X
• 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: 15731497
• MDR Text Key: 303042735
• Report Number: 3000302531-2022-00394
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 12/19/2022

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: D21.535.4X
• Device Lot Number: AA54912117
• 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: 11/04/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2022
• 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: Reuse
• Patient Sequence Number: 1