MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSFLEXISOFTEB17SBRUSHSET4CT; TOOTHBRUSH, POWERED - JEQ

Model Number EB17S

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

I was brushing my teeth, i swallowed the pin - oral-b [accidental device ingestion].Swallowed pin - oral-b [exposure via ingestion].I (swallowed) the pin and i also have the bristles in my mouth / it is a minuscule metal state and it comes out naturally - oral-b [device breakage].Case narrative: adult female consumer via phone reported that while she was brushing her teeth, she swallowed the metal pin and had the bristles in her mouth from the oral-b toothbrush head.No serious injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(6) 2024 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

I was brushing my teeth, i swallowed the pin - oral-b [accidental device ingestion] swallowed pin - oral-b [exposure via ingestion] i (swallowed) the pin and i also have the bristles in my mouth / it is a minuscule metal state and it comes out naturally / brush broke off - oral-b [device breakage] product counterfeit - oral-b [product counterfeit] case narrative: adult female consumer via phone reported that while she was brushing her teeth, she swallowed the metal pin and had the bristles in her mouth from the oral-b toothbrush head.No serious injury was reported.(b)(6) 2024 case update from information initially received on 05-dec-2023: the suspect product was oral-b power power oral care refills flexi soft eb17s brush set 4ct.No serious injury was reported.(b)(6) 2024 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 serious injury was reported.

• Brand Name: ORALBPWRPWRORALCARERFLSFLEXISOFTEB17SBRUSHSET4CT
• 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: 18250525
• MDR Text Key: 330670429
• Report Number: 3000302531-2023-00483
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• 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
• 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
• Patient Sex: Female