MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT; TOOTHBRUSH, POWERED

Model Number EB417

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Consumer contacted via e-mail and stated that one of the two brushes on his/her dual clean brush became detached in his/her mouth.No injury was reported.

Event Description

Consumer contacted via e-mail and stated that one of the two brushes on his/her dual clean brush became detached in his/her mouth.No injury was reported.

Manufacturer Narrative

Product return was received and identified as a non-genuine oral-b product, it was not manufactured under p&g control.

• Brand Name: ORALBPWRPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 9503252
• MDR Text Key: 191197951
• Report Number: 3000302531-2019-00232
• 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
• Type of Report: Initial,Followup
• Report Date: 11/24/2019

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: EB417
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 11/24/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN