MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE4729; TOOTHBRUSH, POWERED - JEQ

Model Number 4729

Device Problems Crack (1135); Battery Problem (2885); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

Oral-b explode [device battery explosion].Light does not light up.Broken, there is a crack in it - oral-b [device physical property issue].Case narrative: consumer via phone stated that the oral-b professional care toothbrush exploded.It was broken and there was a crack in it.No 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

On 28-mar-2023, product investigation results: product return was received and investigated.Product investigation results showed improper consumer handling.

Event Description

Oral-b explode [device battery explosion].Light does not light up.Broken, there is a crack in it - oral-b [device physical property issue].Case narrative: consumer via phone stated that the oral-b professional care toothbrush exploded.It was broken and there was a crack in it.No injury was reported.On 13-feb-2023, amendment from information initially received on 09-feb-2023: the suspect product lot was a 844 311155 of.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE4729
• 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: 16294401
• MDR Text Key: 309507824
• Report Number: 3000302531-2023-00057
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4729
• Device Lot Number: A 844 311155 OF
• 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