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

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Type  malfunction  

Event Description

Bleeding tongue [tongue haemorrhage] bleeding cheek - mouth [mouth haemorrhage] cut cheek - mouth [mouth injury] cut gums [gingival injury] cut tongue [tongue injury] toothbrush the head broke off inside mouth - oral-b [device breakage].Case narrative: a parent via e-mail stated that when their daughter used the oral-b io series 9 electric toothbrush, the oral-b io toothbrush head broke off inside her mouth.When this happened, she cut her gum, tongue, and cheek.No serious injury was reported.04-apr-2024 follow up via digital safety assessment survey: the patient was a 8 year old female.Her cheek and tongue were bleeding.No serious injury was reported.

Manufacturer Narrative

Product return was not received.Product return was requested.Full evaluation will occur upon receipt of product return.

• Brand Name: ORALBPWRORALCARERFLSIOSRS
• 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: 19213369
• MDR Text Key: 342047897
• Report Number: 3000302531-2024-00175
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, IO SERIES 9 (ALL O.
• Patient Age: 8 YR
• Patient Sex: Female