MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3766PRO22000; TOOTHBRUSH, POWERED - JEQ

Model Number 3766

Device Problems Break (1069); Material Erosion (1214)

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

Toothbrush head falls off - oral-b [device breakage].Metal tips of the handle are very sharp/holder has worn down - oral-b [device physical property issue].Case narrative: consumer via e-mail stated that the oral-b toothbrush head fell off and the metal tips of the oral-b toothbrush handle were very sharp.No injury was reported.23-dec-2022 follow up via e-mail and images: the consumer reported that the oral-b holder was worn down.The suspect product was oral-b power rechargeable toothbrush handle 3766 pro 2 2000.The suspect product lot was 2ab95131613.No injury was reported.

Manufacturer Narrative

03-mar-2023 product investigation results: complained product received user handling was identified as root cause for the complaint.

Event Description

Toothbrush head falls off - oral-b [device breakage].Metal tips of the handle are very sharp/holder has worn down - oral-b [device physical property issue].Case narrative: consumer via e-mail stated that the oral-b toothbrush head fell off and the metal tips of the oral-b toothbrush handle were very sharp.No injury was reported.23-dec-2022 follow up via e-mail and images: the consumer reported that the oral-b holder was worn down.The suspect product was oral-b power rechargeable toothbrush handle 3766 pro 2 2000.The suspect product lot was 2ab95131613.No injury was reported.03-feb-2023 case update: the concomitant product was oral-b power power oral care refills precision clean eb20.No injury was reported.03-mar-2023 case update: the concomitant product lot was k112.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3766PRO22000
• 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: 16183396
• MDR Text Key: 308851205
• Report Number: 3000302531-2023-00028
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: DA
• 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: 03/16/2023

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: 3766
• Device Lot Number: 2AB95131613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2023
• 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 (NOT APPLICABLE; ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20 (ORAL-B