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

Device Problem Crack (1135)

Patient Problems Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

The reporter informed the company that the product has been discarded.

Event Description

Cut on tongue from getting head stuck [tongue injury].(crack on the) brush head (and it) got stuck on tongue [foreign body in mouth].Crack on toothbrush head [device physical property issue].A spontaneous report was received via phone on (b)(6) 2022 from a mother reporting that when her 11 year old daughter used oral-b power power oral care refills io series on the morning of (b)(6) 2022, unbeknownst to them, there was a crack in the brush head (2022) and it got stuck on her daughter¿s tongue ((b)(6) 2022).The daughter had a cut on her tongue from getting the (brush) head stuck ((b)(6) 2022).They saw a doctor in accident and emergency (a&e) and were there for 3 hours (on (b)(6) 2022).The brush head was ¿cut through¿ and was still at the hospital.The daughter had to get 3 stitches on the side of her tongue.Product usage details were not provided and it was unknown when product use began.The brush head was last used the morning of (b)(6) 2022, and then product use stopped.The brush head had been used previously with unknown tolerance.The event outcome of cut on tongue was improved.The event outcome of brush head stuck on tongue was recovered ((b)(6) 2022).The case outcome was improved.Relevant history: none reported.Concomitant product(s): oral-b power rechargeable toothbrush handle 3753 io6 series.No further information was provided.

• Brand Name: ORALBPWRPWRORALCARERFLSIOSRS
• 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: 15868343
• MDR Text Key: 304350139
• Report Number: 3000302531-2022-00416
• 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
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORALBPWRRCHGTOOTHBRUSHHANDLE3753IO6SRS (NOT APPLIC
• Patient Outcome(s): Other
• Patient Age: 11 YR
• Patient Sex: Female