MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSCROSSACTNEB50ABBRUSHSET1CT; TOOTHBRUSH, POWERED - JEQ

Model Number EB50AB

Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923)

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

Head becomes loose from the body - oral-b [device connection issue].Head dislocate - oral-b [device breakage].Case narrative: consumer via e-mail stated that the first oral-b cross action toothbrush head dislocated in less than one month.Then, in less than two days, the second oral-b cross action toothbrush head also started to show a similar problem.The oral-b cross action toothbrush head became loose from the body.No injury was reported.

Manufacturer Narrative

02-jun-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

Head becomes loose from the body - oral-b [device connection issue].Head dislocate - oral-b [device breakage].Product counterfeit - oral-b [product counterfeit].Case narrative: consumer via e-mail stated that the first oral-b cross action toothbrush head dislocated in less than one month.Then, in less than two days, the second oral-b cross action toothbrush head also started to show a similar problem.The oral-b cross action toothbrush head became loose from the body.No injury was reported.02-jun-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: ORALBPWRPWRORALCARERFLSCROSSACTNEB50ABBRUSHSET1CT
• 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: 14465812
• MDR Text Key: 300348099
• Report Number: 3000302531-2022-00199
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EB50AB
• Device Lot Number: 97533085
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (O; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (O