MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS8000; TOOTHBRUSH, POWERED - JEQ

Model Number 3765

Device Problems Break (1069); Naturally Worn (2988)

Patient Problems Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

Event Description

Cut lip [lip injury].Cut mouth [mouth injury].Doesn't hold the brush anymore - oral-b [device breakage].Metal shaft on the unit that holds the brush had worn down to thin razor sharp metal - oral-b [device physical property issue].Case narrative: a parent reported via e-mail that the metal shaft that held down the oral-b toothbrush head on the oral-b genius pro 8000 toothbrush had worn down to thin, razor sharp metal.It did not hold the oral-b toothbrush head and their daughter cut her lip and mouth area while brushing when the brush fell off.No serious injury was reported.

Event Description

Cut lip [lip injury].Cut mouth [mouth injury].Doesn't hold the brush anymore - oral-b [device breakage].Metal shaft on the unit that holds the brush had worn down to thin razor sharp metal - oral-b [device physical property issue].Case narrative: a parent reported via e-mail that the metal shaft that held down the oral-b toothbrush head on the oral-b genius pro 8000 toothbrush had worn down to thin, razor sharp metal.It did not hold the oral-b toothbrush head and their daughter cut her lip and mouth area while brushing when the brush fell off.No serious injury was reported.17-jan-2023 case update: the suspect product lot was bb702021756.No serious injury was reported.

Manufacturer Narrative

23-feb-2023 product investigation results: complained product received user handling was identified as root cause for the complaint.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS8000
• 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: 15199254
• MDR Text Key: 304973533
• Report Number: 3000302531-2022-00302
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: SI
• 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: 03/09/2023

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: 3765
• Device Lot Number: BB702021756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: ORALBPWRPWRORALCARERFLS (NOT APPLICABLE),TOOTHBRUS; ORALBPWRPWRORALCARERFLS (NOT APPLICABLE),TOOTHBRUS
• Patient Sex: Female