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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Pinched - lip [lip injury] brush head was loose - oral-b [device connection issue] brush head.Moved side to side while brushing - oral-b [device breakage].Case narrative: adult female consumer via phone reported that her oral-b floss action toothbrush head was loose, moving side to side while brushing, and pinched her lip a few times.No serious injury was reported.

• Brand Name: ORALBPWRORALCARERFLSFLOSSACTN
• 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: 19123800
• MDR Text Key: 340344765
• Report Number: 3000302531-2024-00166
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• 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: ORALBRCHGTOOTHBRUSHHANDLE (ORAL-B/RECHARGEABLE TOO
• Patient Age: 48 YR
• Patient Sex: Female