MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3771GENIUSX; TOOTHBRUSH, POWERED - JEQ

Model Number 3771

Device Problems Detachment of Device or Device Component (2907); Naturally Worn (2988)

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

Event Type  malfunction  

Event Description

Brush heads don¿t stay attached, they come off during brushing - oral-b [device breakage].Pin has become worn down - oral-b [device physical property issue].Case narrative: 29 year old male consumer via phone stated that the pin on his oral-b genius x luxe toothbrush became worn down, and the oral-b original toothbrush heads would not stay attached, coming off during brushing.No injury was reported.

Manufacturer Narrative

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

Event Description

Brush heads don¿t stay attached, they come off during brushing - oral-b [device breakage].Pin has become worn down - oral-b [device physical property issue].Case narrative: 29 year old male consumer via phone stated that the pin on his oral-b genius x luxe toothbrush became worn down, and the oral-b original toothbrush heads would not stay attached, coming off during brushing.No injury was reported.23-dec-2022 case update: the suspect product lot was bh94621315.No injury was reported.23-dec-2022 case update: the concomitant product was oral-b power oral care refills precision clean eb20rb brush set 8ct.No injury was reported.13-feb-2023 case update: the concomitant product lot was (b)(4).No injury was reported.

Manufacturer Narrative

09-feb-2023 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by wear of the driving shaft due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3771GENIUSX
• 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: 15922942
• MDR Text Key: 308025168
• Report Number: 3000302531-2022-00434
• 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: 02/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3771
• Device Lot Number: BH94621315
• 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: ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE; ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20RBBRUSHSE
• Patient Age: 29 YR
• Patient Sex: Male