MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRORALCARERFLSPRECISIONCLEANEB20; TOOTHBRUSH, POWERED - JEQ

Model Number EB20

Device Problem Insufficient Information (3190)

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

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Product return was requested or its in transport.Evaluation will occur upon receipt of product return.

Event Description

Choking [choking] circular brush head came away and got stuck in throat [foreign body in throat] circular brush head came awa.Metal rod snapped off the head - oral-b [device breakage] case narrative: a father reported spontaneously via phone on 26-jun-2023 that three weeks ago on (b)(6), 2023, the metal rod snapped off of his (female of unspecified age) daughter's oral-b power oral care refills, causing the circular part to came away and get stuck in her throat on (b)(6), 2023.He reported that "they" had to remove it (from her throat).She was choking (beginning on (b)(6), 2023, so her two caregivers got her out of the wheelchair and started banging on her back.At the time of this report, she was "okay." she was checked out by a doctor who said that she may have some bruising, but this was not confirmed.It was not specified when she began using the device and continued use of the device was not specified.Additional product usage information was not specified.The adverse event outcomes were: choking - improved; foreign body in throat - recovered on (b)(6), 2023.Exact device used previously: unknown.Concomitant product(s): she used this refill on her oral-b power rechargeable toothbrush handle 3709, which she had for about 15 years (2008).The case outcome was improved.No further information was provided.

Event Description

Choking [choking].Circular brush head came away and got stuck in throat [foreign body in throat].Circular brush head came away, metal rod snapped off the head - oral-b [device breakage].Product counterfeit - oral-b [product counterfeit].Case narrative: a father reported spontaneously via phone on 26-jun-2023 that three weeks ago (on (b)(6) 2023), the metal rod snapped off of his (female of unspecified age) daughter's oral-b power , power oral care refills, causing the circular part to came away and get stuck in her throat (on (b)(6) 2023).He reported that "they" had to remove it (from her throat).She was choking (beginning on (b)(6) 2023), so her two caregivers got her out of the wheelchair and started banging on her back.At the time of this report, she was "okay." she was checked out by a doctor who said that she may have some bruising, but this was not confirmed.It was not specified when she began using the device and continued use of the device was not specified.Additional product usage information was not specified.The adverse event outcomes were: choking - improved; foreign body in throat - recovered on (b)(6) 2023.Exact device used previously: unknown.Concomitant product(s): she used this refill on her oral-b power rechargeable toothbrush handle 3709, which she had for about 15 years (2008).The case outcome was improved.No further information was provided.31-jul-2023, case update from information initially received on 05-jul-2023: the suspect product was oral-b power oral care refills precision clean eb20.The adverse event outcomes remained the same.The case outcome remained the same.No further information was provided.01-aug-2023, case update from information initially received on 05-jul-2023: the concomitant product lot was f104.The adverse event outcomes remained the same.The case outcome remained the same.No further information was provided.09-aug-2023, follow up via phone: the father reported that his daughter was severely physically disabled and she needed everything done for her.This incident occurred while she was having her teeth cleaned.The adverse event outcomes remained the same.The case outcome remained the same.No further information was provided.10-aug-2023, product investigation results: the conclusion code for oral-b power oral care refills precision clean eb20 was: counterfeit product.The product involved was confirmed to be a counterfeit, so the product problem will be removed from the oral-b toothbrush head refill.No injury was reported.

Manufacturer Narrative

10-aug-2023, product investigation results: product return was received and identified as a non-genuine oral-b product, it was not manufactured under p&g control.

• Brand Name: ORALBPWRORALCARERFLSPRECISIONCLEANEB20
• 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 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: 17390014
• MDR Text Key: 319771552
• Report Number: 3000302531-2023-00279
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• 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?: 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: ORALBPWRRCHGTOOTHBRUSHHANDLE3709 (ORAL-B) POWER/REC.; ORALBPWRRCHGTOOTHBRUSHHANDLE3709 (ORAL-B) POWER/REC.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female