MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3767TEEN; TOOTHBRUSH, POWERED - JEQ

Model Number 3767

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

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

A parent via letter stated that their 12 year old (male) son's oral-b toothbrush head would no longer stay attached properly during brushing and there was a small metal plate missing from the pin on the drive unit.No injury was reported.

Event Description

Brush head would no longer stay attached.Small metal plate missing from the pin on the drive unit - oral-b device breakage.Case narrative: a parent via letter stated that their 12 year old (male) son's oral-b toothbrush head would no longer stay attached properly during brushing and there was a small metal plate missing from the pin on the drive unit.No injury was reported.31-mar-2022 case update: the suspect product lot was 3cb11310048.No injury was reported.

Manufacturer Narrative

27-apr-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.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3767TEEN
• Type of Device: TOOTHBRUSH, POWERED - JEQ
• 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: mgr. affairs, oral care-see co ; mason business center 8700; mason-montgomery rd; mason, OH 45040
• MDR Report Key: 13824057
• MDR Text Key: 294026707
• Report Number: 3000302531-2022-00092
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3767
• Device Lot Number: 3CB11310048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2022
• 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 POWER/P.; ORAL-B BRUSHHEADS, VERSION UNKNOWN.
• Patient Age: 12 YR
• Patient Sex: Male