MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRORALCARERFLSPRECISIONCLEANEB20; TOOTHBRUSH, POWERED - JEQ

Model Number EB20

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Bleed - top lip [lip haemorrhage].Stabbed - top lip [lip injury].Painful - top lip [lip pain].Cap has always been a little loose - oral-b [device connection issue].While brushing my teeth the cap literally come off while in my mouth - oral-b [device breakage].Case narrative: consumer via social media reported that the oral-b toothbrush head had always been a little loose.This morning while brushing their teeth, it came off in their mouth and the metal end of the oral-b toothbrush stabbed into their top lip causing it to bleed and be painful.No serious injury was reported.31-jan-2024 via image: the concomitant product was oral-b battery toothbrush handle 3750 base base form.No serious injury was reported.

• Brand Name: ORALBPWRORALCARERFLSPRECISIONCLEANEB20
• 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: 18699597
• MDR Text Key: 336515943
• Report Number: 3000302531-2024-00059
• 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: 02/02/2024

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: EB20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORALBBATTTOOTHBRUSHHANDLE3750BASEBASEFORM (ORAL-B/