MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3756; TOOTHBRUSH, POWERED - JEQ

Model Number 3756

Device Problems Break (1069); Loose or Intermittent Connection (1371); Naturally Worn (2988)

Patient Problem Unspecified Tissue Injury (4559)

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

Injuries - mouth [mouth injury].Brush heads no longer stay securely attached to the hand piece.Constantly gets pulled off the hand piece - oral-b [device breakage].Worn-down hand piece - oral-b [device physical property issue].Coming loose - oral-b [device connection issue].Case narrative: male consumer via e-mail stated that after approximately 3 years of usage, the oral-b toothbrush heads (even brand-new ones) no longer stayed securely attached to the oral-b hand piece.While brushing his teeth, the oral-b toothbrush head constantly got pulled off of the oral-b hand piece, which quickly led to injuries.It was a worn-down hand piece.No serious injury was reported.On 23-may-2022 follow up via e-mail: the suspect product lot was 1 cd920 22002.The consumer reported that the oral-b toothbrush heads kept coming loose.No serious injury was reported.

Event Description

Injuries - mouth [mouth injury].Brush heads no longer stay securely attached to the hand piece.Constantly gets pulled off the hand piece - oral-b [device breakage].Worn-down hand piece - oral-b [device physical property issue].Coming loose - oral-b [device connection issue].Case narrative: male consumer via e-mail stated that after approximately 3 years of usage, the oral-b toothbrush heads (even brand-new ones) no longer stayed securely attached to the oral-b hand piece.While brushing his teeth, the oral-b toothbrush head constantly got pulled off of the oral-b hand piece, which quickly led to injuries.It was a worn-down hand piece.No serious injury was reported.(b)(6) 2022 follow up via e-mail: the suspect product lot was 1 cd920 22002.The consumer reported that the oral-b toothbrush heads kept coming loose.No serious injury was reported.

Manufacturer Narrative

26-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.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3756
• 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): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700; mason-montgomery rd; mason 45040
• MDR Report Key: 14572408
• MDR Text Key: 301190178
• Report Number: 3000302531-2022-00218
• 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: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3756
• Device Lot Number: 1 CD920 22002
• 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 (ORAL-B POWER/P
• Patient Sex: Male