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

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Choking (2464); Foreign Body In Patient (2687)

Event Date 08/05/2023

Event Type  Injury  

Manufacturer Narrative

Product return was not received.Product return was requested.Full evaluation will occur upon receipt of product return.

Event Description

Choking [choking], brush head went straight to throat - oral-b [foreign body in throat].Couldn't breath [dyspnoea], brush head separated from the refill head - oral-b [device breakage].Case narrative: a spontaneous report was received via chat on (b)(6) 2023 from a consumer (unspecified age and gender) stating that this past saturday ((b)(6) 2023) they were brushing their teeth with the oral-b power oral care refills (used on an oral-b rechargeable toothbrush, model 3756).The brush head separated from the refill head and went straight to their throat ((b)(6) 2023).They started choking and couldn¿t breathe (both on (b)(6) 2023).They were not able to speak/ask for help and were not able to take out the brush head with their fingers.They started giving themselves abdominal thrusts against their bathroom sink to try and get the brush head out of their throat, which was successful after multiple tries.They began using the refill device a week prior ((b)(6) 2023) and had been switching to a regular non-electric toothbrush.Additional device usage information was not specified.The adverse event outcomes were: choking and brush head in throat - recovered on (b)(6) 2023; couldn't breathe - unknown.Relevant history: none reported.Exact device used previously: unknown.The case outcome was improved.No further information was provided.09-aug-2023 follow up via digital safety assessment survey: the consumer was a 39-year-old female.She did not contact a health care professional.She used the device for two minutes, three times a day (in the morning, after lunch, and at night).She stopped using the device after the incident occurred on (b)(6) 2023.The adverse event outcomes remained the same.The case outcome remained the same.No further information was provided.

• Brand Name: ORALBPWRORALCARERFLS
• 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): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 17573768
• MDR Text Key: 321517266
• Report Number: 3000302531-2023-00340
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: 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, MODEL 3756 (ALL OT
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female