MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3772; TOOTHBRUSH, POWERED - JEQ

Model Number 3772

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

Face.Blood - skin [skin haemorrhage].Pain like a needle was stuck in face - skin [pain of skin].Small red mark cheek - skin [macule].Small red mark inside the mouth [oral macule].Brush head keep jabbing in the face.Metal prong thing jabbed outside of face - skin [skin injury].Brush head.Came out in mouth.Coming off.Slips off - oral-b [device breakage].Case narrative: adult male consumer via phone stated that the oral-b toothbrush heads kept coming out/coming off/slipping off of the oral-b toothbrush, type 3772, in his mouth while brushing and the metal prong thing jabbed him in the face.There was pain (face), a bit of blood, and a small red mark on his cheek and the inside of his mouth.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: ORALBRCHGTOOTHBRUSHHANDLE3772
• 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: 18908723
• MDR Text Key: 337761020
• Report Number: 3000302531-2024-00101
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3772
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2024
• 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: ORALBPWRORALCARERFLS (ORAL-B/POWER ORAL CARE REFIL.
• Patient Sex: Male