MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3762TRIUMPH; TOOTHBRUSH, POWERED - JEQ

Model Number 3762

Device Problems Break (1069); Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

Scratch inside mouth.Metal pin has poked cheek/injuries [mouth injury].Falling off - oral-b [device breakage].Case narrative: female consumer via phone stated that the oral-b toothbrush head kept falling off of the oral-b toothbrush.The metal pin poked her cheek a few times, leading to injuries, and scratched the inside of her mouth.No serious injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Scratch inside mouth/metal pin has poked cheek/injuries [mouth injury] falling off - oral-b [device breakage] case narrative: female consumer via phone stated that the oral-b toothbrush head kept falling off of the oral-b toothbrush.The metal pin poked her cheek a few times, leading to injuries, and scratched the inside of her mouth.No serious injury was reported.27-mar-2023 case update: the suspect product lot was r42650310.The concomitant product lot was 1031.No injury was reported.11-apr-2023 case update from information initially received on 27-mar-2023: the concomitant product was oral-b power power oral care refills precision clean eb20.No injury was reported.20-apr-2023 case update from information initially received on 27-mar-2023: the concomitant product lot was t0319.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3762TRIUMPH
• 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: 16528604
• MDR Text Key: 311134611
• Report Number: 3000302531-2023-00108
• 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,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3762
• Device Lot Number: R42650310
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE; ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20 (ORAL-B
• Patient Sex: Female