MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE4729; TOOTHBRUSH, POWERED

Model Number 4729

Device Problems Detachment of Device or Device Component (2907); 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 via e-mail stated that their oral-b electric toothbrush brushes fell off quickly.The holder shoot off.No injury was reported.

Manufacturer Narrative

07-feb-2022, concomitant product investigation results: concomitant product return was received and evaluated.No failure could be identified, the concomitant product is according to specifications.

Event Description

Consumer via e-mail stated that their oral-b electric toothbrush brushes fell off quickly.The holder shoot off.No injury was reported.05-nov-2021 case update: the suspect product was updated to oral-b power rechargeable toothbrush handle 4729 and the concomitant product was updated to oral-b power power oral care refills precision clean eb20.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE4729
• 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: 12666660
• MDR Text Key: 279950727
• Report Number: 3000302531-2021-00333
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• 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,Followup
• Report Date: 09/25/2021

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: 4729
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 03/04/2022
• 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
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN.; ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20.