MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20; TOOTHBRUSH, POWERED - JEQ

Model Number EB20

Device Problems Break (1069); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

Heed of it popped off in mouth - oral-b [device breakage].Case narrative: consumer via chat stated that their oral-b crossaction toothbrush refill head popped off of their oral-b toothbrush in their mouth.No injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Head of it popped off in mouth - oral-b [device breakage].Product counterfeit - oral-b [product counterfeit].Case narrative: consumer via chat stated that their oral-b crossaction toothbrush refill head popped off of their oral-b toothbrush in their mouth.No injury was reported.07-apr-2023 product investigation results: the suspect product was oral-b power power oral care refills precision clean eb20.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: ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20
• 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: 16558520
• MDR Text Key: 311747707
• Report Number: 3000302531-2023-00120
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EB20
• 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 (A; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A