MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBMANTOOTHBRUSH; TOOTHBRUSH, MANUAL - EFW

Lot Number 152

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

Cut gums [gingival injury] top set of bristles just fall out - oral-b [device breakage].Case narrative: consumer via social media stated that the top set of bristles just fell out of the oral-b manual toothbrush.The plastic cut 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: ORALBMANTOOTHBRUSH
• Type of Device: TOOTHBRUSH, MANUAL - EFW
• 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: 18845703
• MDR Text Key: 336989737
• Report Number: 3000302531-2024-00092
• Device Sequence Number: 1
• Product Code: EFW
• 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: 03/06/2024

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 Lot Number: 152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• 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: Reuse
• Patient Sequence Number: 1