MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO9SRSM9; TOOTHBRUSH, POWERED - JEQ

Model Number 3758

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)

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

Magnet inside the head on the hand piece is missing.Coming loose mid brushing/gap between the hand piece and the attached brush head - oral-b [device connection issue].Case narrative: male consumer via e-mail stated that the magnet inside of the oral-b toothbrush head on the oral-b io9 toothbrush hand piece was missing from his device, causing the brush head to come loose mid-brushing.No injury was reported.

Manufacturer Narrative

22-dec-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

Magnet inside the head on the hand piece is missing.Coming loose mid brushing/gap between the hand piece and the attached brush head - oral-b [device connection issue].Case narrative: male consumer via e-mail stated that the magnet inside of the oral-b toothbrush head on the oral-b io9 toothbrush hand piece was missing from his device, causing the brush head to come loose mid-brushing.No injury was reported.28-dec-2022 case update: the concomitant product lot was a2020 0125.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO9SRSM9
• 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 ma; son-montgomery rd; mason 45040
• MDR Report Key: 15348884
• MDR Text Key: 305583574
• Report Number: 3000302531-2022-00339
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3758
• Device Lot Number: AH03551854
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORALBPWRPWRORALCARERFLSIOSRS (ORAL-B POWER/POWER O; ORALBPWRPWRORALCARERFLSIOSRS (ORAL-B POWER/POWER O
• Patient Sex: Male