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

Lot Number 1225786000

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Didnt feel great - mouth [oral pain].Started to feel something strange in mouth.Found a metal pin that came out of the brush head.Broken - oral-b [device breakage].Case narrative: consumer via chat stated that they started to feel something strange in their mouth and they found a metal pin that came out of the oral-b cross action toothbrush head.They reported that it "did not feel great." no serious injury was reported.27-feb-2024 follow up via digital safety assessment survey: the consumer was a 42 year old male.No serious injury was reported.

• Brand Name: ORALBPWRORALCARERFLSCROSSACTNANTIBAC
• 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): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 18908767
• MDR Text Key: 337745821
• Report Number: 3000302531-2024-00105
• 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
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1225786000
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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.
• Patient Age: 42 YR
• Patient Sex: Male