MAUDE Adverse Event Report: HAND HELD HAND PIECES

Device Problem Device Stops Intermittently (1599)

Patient Problems Burning Sensation (2146); Burn, Thermal (2530)

Event Date 11/10/2014

Event Type  Injury  

Event Description

Yesterday i took my daughter to the dentist at (b)(6).She saw dr.(b)(6) this was her first apt so she had x-rays, exam and a cleaning, during the cleaning the lady kept stopping because the ele hand held device she was using kept giving her problems and finally she called a different dr in and he kept adjusting it, after we left my daughter said her mouth was burning real bad and she has blisters in her mouth, my daughter said that the device they were using was burning her.The walter was scalding hot the dentist kept saying sorry to her, my daughter has to be given a sedative in order to even go to the dentist or doctor.She had severe anxiety disorder that causes panic attacks, that's why she didn't say anything else.She is (b)(6) years old and we need help.The dentist was really nice but that doesn't make it right and now my daughter doesn't want to ever go back.What should i do.Thank you.

• Brand Name: HAND HELD HAND PIECES
• Type of Device: HAND HELD HAND PIECES
• MDR Report Key: 4265238
• MDR Text Key: 21089709
• Report Number: MW5039091
• Device Sequence Number: 1
• Product Code: EFB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/11/2014

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?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/11/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Weight: 50