MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPWRPLSHREB17SBRUSHSET1CT; TOOTHBRUSH, POWERED - JEQ

Model Number EB17S

Device Problem Misconnection (1399)

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

Event Type  malfunction  

Manufacturer Narrative

The reporter informed the company that the product has been discarded.

Event Description

Brush head came loose - oral-b [device connection issue].Case narrative: male consumer via e-mail stated that the oral-b flexisoft replacement brush heads came loose from his oral-b toothbrush after just a short period of time.No injury was reported.

Manufacturer Narrative

(b)(6)2022 product investigation results: product return was received and identified as a non-genuine oral-b product, it was not manufactured under p&g control.

Event Description

Brush head came loose - oral-b [device connection issue] product counterfeit - oral-b [product counterfeit] case narrative: male consumer via e-mail stated that the oral-b flexisoft replacement brush heads came loose from his oral-b toothbrush after just a short period of time.No injury was reported.(b)(6)2022 product investigation results: the product involved was confirmed to be a counterfeit, so the product problem will be removed from the oral-b toothbrush head refill.No injury was reported.

• Brand Name: ORALBPWRPWRORALCARERFLSPWRPLSHREB17SBRUSHSET1CT
• 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: 15658153
• MDR Text Key: 306881536
• Report Number: 3000302531-2022-00386
• 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: 11/15/2022

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: EB17S
• 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: 10/24/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2022
• 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
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A
• Patient Sex: Male