MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3756; TOOTHBRUSH, POWERED - JEQ

Model Number UNSP REG#-20220421022448

Device Problems Break (1069); Failure to Charge (1085); Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The reporter informed the company that the product has been discarded.

Event Description

Female consumer via phone stated that her oral-b pro 700 toothbrush no longer charged; the power cord broke around the plug for the charger; and the wires were visible.The fuse blew and the power outlet was charred.No injury was reported.(b)(6) 2022 case update: the suspect product was oral-b power rechargeable toothbrush handle 3756.No injury was reported.

Manufacturer Narrative

26-mar-2022 product investigation results: product return was received and investigated.Product investigation results showed that complaint was caused by a breakage of the mains cable due to improper consumer handling.

Event Description

No longer charges, power cord broke, wires are visible, fuse blew, and the power outlet was charred - oral-b [device physical property issue] case narrative: female consumer via phone stated that her oral-b pro 700 toothbrush no longer charged; the power cord broke around the plug for the charger; and the wires were visible.The fuse blew and the power outlet was charred.No injury was reported.17-feb-2022 case update: the suspect product was oral-b power rechargeable toothbrush handle 3756.No injury was reported.25-feb-2022 case update: the suspect product lot was 1ab10721635.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3756
• 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 D-978 28; GM D-97828
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700; mason-montgomery rd; mason, OH 45040
• MDR Report Key: 13563029
• MDR Text Key: 294026651
• Report Number: 3000302531-2022-00058
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNSP REG#-20220421022448
• Device Lot Number: 1AB10721635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2022
• 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
• Patient Sex: Female