MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLEPRO; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problems Thermal Decomposition of Device (1071); Material Puncture/Hole (1504)

Patient Problems Skin Discoloration (2074); Burn, Thermal (2530); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

Assessment of the complaint (with only provided data): this report is being filed due to a melted hole in the handle.It has been determined that a melted area on housing of the handle could have been caused by a short circuit overheating the pcb/motor transistor.Our assessment is that while it is not probable that such a malfunction would lead to a serious injury, we cannot foreclose that possibility.Therefore, out of an abundance of caution, we are reporting to the fda.The product has been requested and an investigation will be conducted upon its arrival.

Event Description

Shocked [electric shock].Burned tip of left thumb- toothbrush [thermal burn].White color to tip of left thumb- hand [skin discolouration].Pain - thumb [pain in extremity].Toothbrush shocked, burned through the plastic on top of the power button / burned through to where there is a hole now [device physical property issue].A parent called and stated that his/her daughter was using a toothbrush and it shocked her; the plastic on top of the toothbrush's power button was burned through to where there is a hole now.No serious injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLEPRO
• Type of Device: TOOTHBRUSH, POWERED
• 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: regulatory oral care ; 8700 mason-montgomery rd; mason, OH 45040
• MDR Report Key: 8450989
• MDR Text Key: 139963168
• Report Number: 3000302531-2019-00046
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• 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
• Patient Age: 16 YR