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

Model Number EB20

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Discomfort (2330)

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

Uncomfortable [discomfort].Head became loose on the handle - oral-b [device connection issue].Case narrative: consumer via e-mail stated that the oral-b toothbrush head became loose on the oral-b toothbrush handle, making it difficult and uncomfortable to use.No serious injury was reported.

Manufacturer Narrative

25-jan-2023 case update: the reporter informed the company that the product has been discarded.

Event Description

Uncomfortable [discomfort]; head became loose on the handle - oral-b [device connection issue].Case narrative: consumer via e-mail stated that the oral-b toothbrush head became loose on the oral-b toothbrush handle, making it difficult and uncomfortable to use.No serious injury was reported.23-jan-2023 follow up via images: the suspect product was oral-b power oral care refills precision clean eb20.No serious injury was reported.25-jan-2023 follow up via e-mail: the consumer reported that the device was discarded.No serious injury was reported.

• 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 ma; son-montgomery rd; mason 45040
• MDR Report Key: 16136502
• MDR Text Key: 308837632
• Report Number: 3000302531-2023-00013
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (O).; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (O).