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

Device Problems Break (1069); No Apparent Adverse Event (3189); Sharp Edges (4013)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

Metal top part of the actual brush has gone straight into lip [lip injury].Head has just come off - oral-b [device breakage].A spouse via e-mail stated that their husband had been using his oral-b toothbrush and the oral-b toothbrush head came off.The metal, top part of the actual oral-b toothbrush went straight into his lip causing a pretty severe injury.No serious injury was reported.On (b)(6) 2023 follow up via images: the concomitant product was oral-b genius x.No serious injury was reported.On (b)(6) 2023 follow up via images: the concomitant product was oral-b power rechargeable toothbrush handle 3765 genius.The concomitant product lot was bc103310641.No serious injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(6) 2023 concomitant product investigation results: concomitant product return was received and evaluated.No failure could be identified, the product is according to specifications.

Event Description

Metal top part of the actual brush has gone straight into lip.Injury [lip injury] head has just come off - oral-b [device breakage] case narrative: a spouse via e-mail stated that their husband had been using his oral-b toothbrush and the oral-b toothbrush head came off.The metal, top part of the actual oral-b toothbrush went straight into his lip causing a pretty severe injury.No serious injury was reported.25-feb-2023 follow up via images: the concomitant product was oral-b genius x.No serious injury was reported.28-feb-2023 follow up via images: the concomitant product was oral-b power rechargeable toothbrush handle 3765 genius.The concomitant product lot was bc103310641.No serious injury was reported.

• Brand Name: ORALBPWRPWRORALCARERFLSTRIZONE
• 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): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld D-978 28; GM D-97828
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 16520949
• MDR Text Key: 311141116
• Report Number: 3000302531-2023-00112
• 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,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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
• Is the Reporter a Health Professional?: 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: ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS (ORAL-B POW; ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS (ORAL-B POW
• Patient Sex: Male