MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSFLOSSACTNEB25; TOOTHBRUSH, POWERED - JEQ

Model Number EB25

Device Problems Break (1069); Product Quality Problem (1506); No Apparent Adverse Event (3189); Noise, Audible (3273)

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 would break.Snap sound - oral-b [device breakage].Counterfeit toothbrush heads - oral-b [suspected counterfeit product].Case narrative: consumer via chat stated that the oral-b floss action toothbrush head would break within 1-3 weeks of use.They heard a snap sound while using the fake head.No injury was reported.

Event Description

Head would break.Snap sound - oral-b [device breakage].Product counterfeit - oral-b [product counterfeit].Case narrative: consumer via chat stated that the oral-b floss action toothbrush head would break within 1-3 weeks of use.They heard a snap sound while using the fake head.No injury was reported.09-mar-2023 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.

Manufacturer Narrative

09-mar-2023 product investigation results: product was identified as a non genuine oral b product, it was not manufactured under p&g control.

• Brand Name: ORALBPWRPWRORALCARERFLSFLOSSACTNEB25
• 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: 16294342
• MDR Text Key: 308888825
• Report Number: 3000302531-2023-00058
• 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: 04/02/2023

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: EB25
• 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
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A