MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3766; TOOTHBRUSH, POWERED - JEQ

Model Number 3766

Device Problems Break (1069); Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem 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

Stab - mouth [mouth injury].Head comes off - oral-b [device breakage].Head shaft looks like has worn - oral-b [device physical property issue].Case narrative: consumer via e-mail stated that the oral-b pro replacement toothbrush heads came off of their oral-b pro 1 680 toothbrush and they have stabbed themselves a few times with it.The oral-b toothbrush head shaft looked like it had worn.No serious injury was reported.

Manufacturer Narrative

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

Event Description

Stab - mouth [mouth injury].Head comes off - oral-b [device breakage].Head shaft looks like has worn - oral-b [device physical property issue].Case narrative: consumer via e-mail stated that the oral-b pro replacement toothbrush heads came off of their oral-b pro 1 680 toothbrush and they have stabbed themselves a few times with it.The oral-b toothbrush head shaft looked like it had worn.No serious injury was reported.08-sep-2022 case update: the suspect product was oral-b power rechargeable toothbrush handle 3766.No serious injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3766
• 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: 15348521
• MDR Text Key: 305641051
• Report Number: 3000302531-2022-00341
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• 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: 2 CB90211500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• 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: ORAL-B BRUSHHEADS, PRO VERSION (ALL OTHER NON-THER; ORAL-B BRUSHHEADS, PRO VERSION (ALL OTHER NON-THER