MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRORALCARERFLSDUALACTNEB417; TOOTHBRUSH, POWERED - JEQ

Model Number EB417

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

Stabbed in the lip by the metal shaft that the brush head attaches too [lip injury].Small cut above lip from where the metal piece of toothbrush jabbed into (skin) [skin laceration].Above lip.Bled - skin [skin haemorrhage].Head slid off - oral-b [device breakage].Doesn't quite fit correctly as it should - oral-b [device connection issue].Case narrative: consumer via e-mail stated that the oral-b dual toothbrush head slid off and they got stabbed in the lip by the metal shaft that the oral-b toothbrush head attached to on the oral-b toothbrush.No serious injury was reported.21-mar-2024 follow up via digital safety assessment survey: the consumer was a 47 year old male.He experienced a small cut that bled above his lip from where the metal piece of the oral-b toothbrush jabbed into him.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: ORALBPWRORALCARERFLSDUALACTNEB417
• 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: 19036855
• MDR Text Key: 339683180
• Report Number: 3000302531-2024-00153
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EB417
• 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: ORALBRCHGTOOTHBRUSHHANDLE (ORAL-B/RECHARGEABLE. TOO; TOOTHPASTE ().
• Patient Age: 47 YR
• Patient Sex: Male