MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS10000N; TOOTHBRUSH, POWERED

Model Number 3765

Device Problems Break (1069); Device Slipped (1584); Separation Problem (4043)

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

Female consumer via e-mail stated that a piece broke off of the metal pin to which she attached the brush head to her oral-b genius 10000n electric toothbrush.The brush heads could still be attached, but they did not stay attached securely and kept slipping off during brushing.No injury was reported.

Manufacturer Narrative

31-jan-2022 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

Female consumer via e-mail stated that a piece broke off of the metal pin to which she attached the brush head to her oral-b genius 10000n electric toothbrush.The brush heads could still be attached, but they did not stay attached securely and kept slipping off during brushing.No injury was reported.03-nov-2021 case update: product lot: bc908071535.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS10000N
• 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: 12657553
• MDR Text Key: 279784833
• Report Number: 3000302531-2021-00335
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• 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: 09/23/2021

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: 3765
• Device Lot Number: BC908071535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/22/2022
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN.; ORAL-B BRUSHHEADS, VERSION UNKNOWN.
• Patient Sex: Female