MAUDE Adverse Event Report: ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS10100SMODELD701.544.6XC; TOOTHBRUSH, POWERED

Model Number D701.544.6XC

Device Problems Loose or Intermittent Connection (1371); 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

Female consumer via phone stated that her brush head sat loosely on her oral-b genius 10100s hand piece and fell off while brushing her teeth.No injury was reported.

Manufacturer Narrative

23-sep-2021 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by wear of the driving shaft due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.

Event Description

Female consumer via phone stated that her brush head sat loosely on her oral-b genius 10100s hand piece and fell off while brushing her teeth.No injury was reported.16-sep-2021 case updated received: concomitant product updated to oral-b power power oral care refills crossaction eb50.No further information was provided.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS10100SMODELD701.544.6XC
• Type of Device: TOOTHBRUSH, POWERED
• MDR Report Key: 12360817
• MDR Text Key: 274443333
• Report Number: 3000302531-2021-00284
• 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: 08/06/2021

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: D701.544.6XC
• Device Lot Number: BC812070153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2021
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 10/14/2021
• 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
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN; ORALBPWRPWRORALCARERFLSCROSSACTNEB50