MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUSX; TOOTHBRUSH, POWERED - JEQ

Model Number 3765

Device Problems Break (1069); Degraded (1153); Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

Lip bled [lip haemorrhage].Lip burst open/poked lip [lip injury].Brush head fell off - oral-b [device breakage].Metal pin on the old toothbrush is pretty worn down - oral-b [device physical property issue].Case narrative: adult female consumer via phone stated that she pulled her oral-b genius x toothbrush out of her mouth after brushing and the oral-b toothbrush head fell off.The oral-b toothbrush poked her lip in the process, bursting it open and causing it to bleed.The metal pin on the toothbrush was pretty worn down.No serious injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

On 16-mar-2023, product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by wear of the driving shaft due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.

Event Description

Lip bled [lip haemorrhage].Lip burst open/poked lip [lip injury].Brush head fell off - oral-b [device breakage].Metal pin on the old toothbrush is pretty worn down - oral-b [device physical property issue].Case narrative: adult female consumer via phone stated that she pulled her oral-b genius x toothbrush out of her mouth after brushing and the oral-b toothbrush head fell off.The oral-b toothbrush poked her lip in the process, bursting it open and causing it to bleed.The metal pin on the toothbrush was pretty worn down.No serious injury was reported.On 27-feb-2023, case update: the suspect product lot was bc901282230.No serious injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUSX
• 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: 16375117
• MDR Text Key: 309594125
• Report Number: 3000302531-2023-00079
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 04/10/2023

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: BC901282230
• 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: 02/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN ; ORAL-B BRUSHHEADS, VERSION UNKNOWN
• Patient Sex: Female