MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3772; TOOTHBRUSH, POWERED - JEQ

Model Number 3772

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

Injure gums [gingival injury] pin that¿s supposed to hold the brush head in place is broken / brush head just slips off mid-brushing - oral-b [device breakage] case narrative: consumer via e-mail reported that the pin on their oral-b toothbrush handle, type 3772 was broken and the oral-b toothbrush head slipped off mid-brushing causing them to injury their gums.No serious injury was reported.

Manufacturer Narrative

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

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE3772
• 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): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 18980196
• MDR Text Key: 339557551
• Report Number: 3000302531-2024-00145
• 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
• Report Date: 03/26/2024

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: 3772
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• 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: ORALBPWRORALCARERFLS (ORAL-B/POWER ORAL CARE REFIL