MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3766PRO2950PUREPLAY; TOOTHBRUSH, POWERED - JEQ

Model Number 3766

Device Problems Loose or Intermittent Connection (1371); Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Brush is loose on brush, it won¿t stay in place - oral-b [device connection issue].Top of the metal pin is shorter - oral-b [device physical property issue].Case narrative: male consumer via phone stated that the oral-b toothbrush head was loose on his oral-b toothbrush (type number 3766).It would not stay in place and it seemed like the top of the metal pin was shorter.No injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

01-sep-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

Brush is loose on brush, it won¿t stay in place - oral-b [device connection issue].Top of the metal pin is shorter - oral-b [device physical property issue].Case narrative: male consumer via phone stated that the oral-b toothbrush head was loose on his oral-b toothbrush (type number 3766).It would not stay in place and it seemed like the top of the metal pin was shorter.No injury was reported.19-aug-2022 case update: the suspect product lot was 2cb03021940.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3766PRO2950PUREPLAY
• 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 45040
• MDR Report Key: 15223732
• MDR Text Key: 303727800
• Report Number: 3000302531-2022-00306
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3766
• Device Lot Number: 2CB03021940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• 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 (NOT APPLICABLE; ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE
• Patient Sex: Male