MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3766PRO2500; TOOTHBRUSH, POWERED - JEQ

Model Number 3766

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Laceration(s) (1946); Scar Tissue (2060); 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 nose [skin laceration].Scarred [scar].Scabbed [scab].Brush head detached from the handle - oral-b [device breakage].Case narrative: consumer via e-mail stated that yesterday while brushing their teeth (on (b)(6) 2022), the oral-b toothbrush head suddenly detached from the oral-b handle.The handle in iron alone cut their nose and they had "the mark of the iron handle near their nostril." no serious injury was reported.(b)(6) 2022 follow up via phone: the 50 year old female consumer stated that the previously reported adverse event scarred with a scab.Since the incident, she used a manual toothbrush.She had not been to see a doctor; reported having no allergies; and had always used oral-b.She applied a healing cream for treatment.No serious injury was reported.

Manufacturer Narrative

12-sep-2022 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by a breakage of the tip of the driving shaft due to improper consumer handling, storing and cleaning of the product.

Event Description

Cut nose [skin laceration].Scarred [scar].Scabbed [scab].Brush head detached from the handle - oral-b [device breakage].Case narrative: consumer via e-mail stated that yesterday while brushing their teeth (on (b)(6) 2022), the oral-b toothbrush head suddenly detached from the oral-b handle.The handle in iron alone cut their nose and they had "the mark of the iron handle near their nostril." no serious injury was reported.05-apr-2022 follow up via phone: the 50 year old female consumer stated that the previously reported adverse event scarred with a scab.Since the incident, she used a manual toothbrush.She had not been to see a doctor; reported having no allergies; and had always used oral-b.She applied a healing cream for treatment.No serious injury was reported.26-may-2022 follow up via e-mail: the suspect product was an oral-b power rechargeable toothbrush handle 3766 pro 2500.No serious injury was reported.14-jun-2022 case update: the suspect product lot was 2ab93720055.No serious injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3766PRO2500
• 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; mason-montgomery rd; mason 45040
• MDR Report Key: 14433325
• MDR Text Key: 300320414
• Report Number: 3000302531-2022-00195
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 09/27/2022

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: 3766
• Device Lot Number: 2AB93720055
• 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: 05/19/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2022
• 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 (ALL OTHER NON-; ORAL-B BRUSHHEADS, VERSION UNKNOWN (ALL OTHER NON-
• Patient Age: 50 YR
• Patient Sex: Female