MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3753IOSRS6M6; TOOTHBRUSH, POWERED - JEQ

Model Number 3753

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Pain (1994); Superficial (First Degree) Burn (2685); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Type  malfunction  

Event Description

Burned the left side of inner mouth - oral-b [burn oral cavity].1st degree burn - oral-b [burns first degree].Wound inside - mouth [mouth injury].Sensitivity and moderate amt of pain with any movement of cheek - mouth [oral pain].Swelling.Left cheek - mouth [mouth swelling].Wisps of smoking coming from the toothbrush - oral-b [device catching fire].Head of the toothbrush started to get hot - oral-b [device temperature issue].Case narrative: 35 year old female consumer (physician assistant) via chatbot stated that the oral-b io toothbrush head of the oral-b io series 6 electric toothbrush, type 3753 started to get hot and burned the left side of her inner mouth mid-brushing, with wisps of smoking coming from the oral-b io toothbrush.She experienced sensitivity and a moderate amount of pain with any movement of her cheek.Her examination findings were consistent with a first degree burn.No serious injury was reported.21-mar-2024 follow up via e-mail: the consumer reported that she had a wound inside of her mouth and swelling was visibly noticeable from the outside of her left cheek.No serious injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(6) 2024 case update: based on updated assessment provided by gps no reportable event has taken place to the consumer.Hence the actual mdr is obsolete and no longer needed.

Event Description

Burned the left side of inner mouth - oral-b [burn oral cavity] 1st degree burn - oral-b [burns first degree] wound inside - mouth [mouth injury] sensitivity and moderate amt of pain with any movement of cheek - mouth [oral pain] swelling.Left cheek - mouth [mouth swelling] wisps of smoking coming from the toothbrush - oral-b [device catching fire] head of the toothbrush started to get hot - oral-b [device temperature issue] case narrative: 35 year old female consumer (physician assistant) via chatbot stated that the oral-b io toothbrush head of the oral-b io series 6 electric toothbrush, type 3753 started to get hot and burned the left side of her inner mouth mid-brushing, with wisps of smoking coming from the oral-b io toothbrush.She experienced sensitivity and a moderate amount of pain with any movement of her cheek.Her examination findings were consistent with a first degree burn.No serious injury was reported.21-mar-2024 follow up via e-mail: the consumer reported that she had a wound inside of her mouth and swelling was visibly noticeable from the outside of her left cheek.No serious injury was reported.(b)(6) 2024 case update: based on updated assessment provided by gps no reportable event has taken place to the consumer.Hence the actual mdr is obsolete and no longer needed.No serious injury was reported.

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE3753IOSRS6M6
• 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: 19123795
• MDR Text Key: 341256413
• Report Number: 3000302531-2024-00183
• 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: Health Professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3753
• Device Lot Number: AM 31830249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2024
• 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
• Patient Age: 35 YR
• Patient Sex: Female