MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3754PRO3000; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problem Fluid/Blood Leak (1250)

Patient Problems Caustic/Chemical Burns (2549); Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

This report is being filed due to a reported serious ae.Product return was not received.Product return was requested.Full evaluation will occur upon receipt of returned product.

Event Description

Burnt hand - battery acid from oral-b electric toothbrush (chemical burn of skin).Battery in the toothbrush leaked out acid and burnt hand - oral-b toothbrush (accidental exposure to product).Battery in the toothbrush has leaked out acid onto hand (exposure via skin contact).Battery in the toothbrush has leaked out acid - oral-b electric toothbrush (device battery issue).Case description: the consumer, unspecified age and gender, reported spontaneously via email on 24-jul-2019 that he/she used the oral-b power rechargeable toothbrush handle 3754 pro 3000, beginning on an unspecified date.The battery in the toothbrush leaked out acid and burned his/her hand.The consumer had emergency surgery to reconstruct his/her hand.It was unknown if the consumer previously used this exact same type of toothbrush in the past.Relevant history: none reported.Concomitant product(s): none reported.The outcome of the symptoms were unknown.The overall case outcome was unknown.No further information was provided.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3754PRO3000
• Type of Device: TOOTHBRUSH, POWERED
• 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: regulatory oral care ; 8700 mason-montgomery rd; mason, OH 45040
• MDR Report Key: 8906406
• MDR Text Key: 158139330
• Report Number: 3000302531-2019-00150
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2019
• 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
• Patient Outcome(s): Other