MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3709; TOOTHBRUSH, POWERED

Model Number 3709

Device Problems Disconnection (1171); Device Fell (4014)

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

Event Type  malfunction  

Manufacturer Narrative

Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

Event Description

Consumer called stating the brush heads did not stay attached to the hand piece of the toothbrush, and would fall off while in use.No injury was reported.

Manufacturer Narrative

(b)(6)2021 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by a breakage of the tip of the driving shaft due to improper consumer handling, storing and cleaning of the product.

Event Description

Consumer called stating the brush heads did not stay attached to the hand piece of the toothbrush, and would fall off while in use.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3709
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 11338634
• MDR Text Key: 233555865
• Report Number: 3000302531-2021-00054
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3709
• Device Lot Number: R71511600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL-B POWER/POWER ORAL CARE REFILLS/CROSSACTION; ORALBPWRPWRORALCARERFLSCROSSACTNEB50