MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; TOOTHBRUSH, POWERED - JEQ

Device Problem No Apparent Adverse Event (3189)

Patient Problems Burn(s) (1757); Tinnitus (2103)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Ringing in ear [tinnitus], burn spot - skin [thermal burn], charger exploded - oral-b [device battery explosion].Case narrative: female consumer via phone stated that the oral-b toothbrush charger exploded.She experienced a burn spot and constant heard ringing in her ear.No serious injury was reported.

• Brand Name: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
• 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: 17032466
• MDR Text Key: 316292990
• Report Number: 3000302531-2023-00232
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 05/31/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• 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
• Patient Sex: Female