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

Model Number 4729

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

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

Male consumer via e-mail stated that his oral-b brush heads (the originals) kept falling off.No injury was reported.16-aug-2021 follow up via e-mail: male consumer via e-mail stated that he used the brush heads on his oral-b professional care toothbrush model 4729.No injury was reported.

Manufacturer Narrative

On 08-jun-2022: product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by wear of the driving shaft and plastic parts due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.

Event Description

(oral-b) brush heads (the originals) keep falling off now [device breakage].Case narrative: male consumer via e-mail stated that his oral-b brush heads (the originals) kept falling off.No injury was reported.On 16-aug-2021: follow up via e-mail: male consumer via e-mail stated that he used the brush heads on his oral-b professional care toothbrush model 4729.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; mason-montgomery rd; mason, OH 45040
• MDR Report Key: 12391195
• MDR Text Key: 270505409
• Report Number: 3000302531-2021-00294
• 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: 06/28/2022

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: 4729
• Device Lot Number: 1BD 842 506 34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 06/28/2022
• 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
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN; ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE)
• Patient Sex: Male