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

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

Cut the inside of lip/small nick inside lip [lip injury].Oral-b cross action heads broke seems the mechanism is broken on the inside [device breakage].Case narrative: consumer via e-mail stated that the oral-b crossaction toothbrush heads broke.It seemed like the mechanism was broken on the inside and it cut the inside of their lip.No serious injury was reported.(b)(6) 2024 follow up via digital safety assessment survey: the consumer was a 27 year old male.No serious injury was reported.

Manufacturer Narrative

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

• 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: 18908768
• MDR Text Key: 337794403
• Report Number: 3000302531-2024-00102
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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: 03/01/2024

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
• 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: ORALBRCHGTOOTHBRUSHHANDLE (ORAL-B/RECHARGEABLE TOO
• Patient Age: 27 YR
• Patient Sex: Male