MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3764; TOOTHBRUSH, POWERED - JEQ

Model Number 3764

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

Choke [choking] (toothbrush head) slid down my mouth into throat/lodged at the back of throat - oral-b [foreign body in throat] came fully off.Metal shaft has snapped completely off - oral-b [device breakage] toothbrush head.So loose that it slides partially off when brushing - oral-b [device connection issue].Case narrative: consumer via e-mail stated that the oral-b toothbrush head came fully off of the oral-b toothbrush handle while brushing their teeth, causing them to choke as it slide down their mouth into their throat.The top of the metal shaft of the oral-b toothbrush handle snapped completely off.No serious injury was reported.(b)(6) 2023 follow-up via e-mail and pictures: the consumer reported that they were "okay." the suspect product was oral-b power rechargeable toothbrush handle 3764 and the suspect product lot was r94131901.The concomitant product was oral-b power oral care refills crossaction eb50 and the concomitant product lot was 91831058.No serious injury was reported.(b)(6) 2023 follow up via digital safety assessment survey: the consumer was a 30 year old male.No serious injury was reported.

Manufacturer Narrative

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

Event Description

Choke [choking].(toothbrush head) slid down my mouth into throat/lodged at the back of throat - oral-b [foreign body in throat].Came fully off.Metal shaft has snapped completely off - oral-b [device breakage] toothbrush head.So loose that it slides partially off when brushing - oral-b [device connection issue].Case narrative: consumer via e-mail stated that the oral-b toothbrush head came fully off of the oral-b toothbrush handle while brushing their teeth, causing them to choke as it slide down their mouth into their throat.The top of the metal shaft of the oral-b toothbrush handle snapped completely off.No serious injury was reported.20-jul-2023 follow-up via e-mail and pictures: the consumer reported that they were "okay." the suspect product was oral-b power rechargeable toothbrush handle (b)(6) and the suspect product lot was r94131901.The concomitant product was oral-b power power oral care refills crossaction eb50 and the concomitant product lot was 91831058.No serious injury was reported.20-jul-2023 follow up via digital safety assessment survey: the consumer was a 30 year old male.No serious injury was reported.

Manufacturer Narrative

25-sep-2023 product investigation results: complained product received - user handling was identified as root cause for the complaint.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3764
• 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: 17510360
• MDR Text Key: 320904588
• Report Number: 3000302531-2023-00331
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3764
• Device Lot Number: R94131901
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: ORALBPWRPWRORALCARERFLSCROSSACTNEB50 (ORAL-B POWER; ORALBPWRPWRORALCARERFLSCROSSACTNEB50 (ORAL-B POWER
• Patient Age: 30 YR
• Patient Sex: Male