MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20; TOOTHBRUSH, POWERED - JEQ

Model Number EB20

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Connection Problem (2900); Naturally Worn (2988)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

Poked cheek - skin [skin injury].Brush heads come loose - oral-b [device connection issue] plastic on the top of the hand piece is worn off - oral-b [device physical property issue].Case narrative: male consumer via phone stated that the oral-b precision clean toothbrush heads came loose during brushing with his oral-b triumph professional care toothbrush and one time, the metal pin poked him in the cheek.No serious injury was reported.(b)(6) 2022 follow up via phone: the plastic on the top of the oral-b hand piece was worn off.No serious 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

Poked cheek - skin [skin injury] brush heads come loose - oral-b [device connection issue] plastic on the top of the hand piece is worn off - oral-b [device physical property issue] case narrative: male consumer via phone stated that the oral-b precision clean toothbrush heads came loose during brushing with his oral-b triumph professional care toothbrush and one time, the metal pin poked him in the cheek.No serious injury was reported.26-apr-2022 follow up via phone: the plastic on the top of the oral-b hand piece was worn off.No serious injury was reported.31-may-2022 case update: the concomitant product was oral-b power rechargeable toothbrush handle 3764 and the concomitant product lot was r60851041.No serious injury was reported.

Manufacturer Narrative

30-jun-2022 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by wear of the driving shaft and plastic parts due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.

• Brand Name: ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20
• 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: 14427031
• MDR Text Key: 300304056
• Report Number: 3000302531-2022-00192
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EB20
• 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: ORALBPWRRCHGTOOTHBRUSHHANDLE3762TRIUMPH (ORAL-B PO).; ORALBPWRRCHGTOOTHBRUSHHANDLE3764 (ORAL-B POWER/REC).
• Patient Sex: Male