MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3766; TOOTHBRUSH, POWERED - JEQ

Model Number 3766

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

Not caused any health issues [no adverse event] toothbrush head is not staying on the metal pin on the top.Fell off the handle - oral-b [device breakage] come loose - oral-b [device connection issue] toothbrush the battery is no longer charges - oral-b [device power source issue].Case narrative: a 67-year-old female consumer via phone stated that the oral-b trizone toothbrush head was not staying on the metal pin on top of the oral-b toothbrush, type 3766, and fell off.It came loose while brushing her teeth.The toothbrush battery also no longer charged.None of this caused any health issues.No injury was reported.18-apr-2024 case update: the suspect product lot was 2ab94452143.No injury was reported.

Manufacturer Narrative

Product return was requested or its in transport.Evaluation will occur upon receipt of product return.

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE3766
• 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 ma; son-montgomery rd; mason 45040
• MDR Report Key: 19213075
• MDR Text Key: 342018029
• Report Number: 3000302531-2024-00196
• 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
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3766
• Device Lot Number: 2AB94452143
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ORALBPWRORALCARERFLSTRIZONE (ORAL-B/POWER ORAL CAR
• Patient Age: 67 YR
• Patient Sex: Female