MAUDE Adverse Event Report: DISCUS DENTAL, LLC ZOOM AP LAMP

Model Number ZOOM AP 2.5

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Swelling (2091); Sensitivity of Teeth (2427); Full thickness (Third Degree) Burn (2696)

Event Date 05/07/2014

Event Type  No Answer Provided  

Event Description

An extensive investigation was conducted for complaint # (b)(4).On (b)(6) 2014, (b)(6) called to report that they had an injury during a zoom whitening procedure.They stated that pt kept moving causing the gel to burn lip.After completing the zoom teeth whitening procedure, the pt complained of very sensitive teeth and swollen lip.The pt ended up getting a 3rd degree burn inside the mouth on the right side.The pt's right side of the neck including the glands was swollen for a day.The pt went to the emergency room and was given antibiotic and pain pills.

Manufacturer Narrative

The investigation included review of the batch history records for the sku # 22-3764, lot # 13245045.The review of the batch history records did not uncover any adverse finding.In addition, the retain sample for sku # 22-3764, lot # 13245045 was tested and was found to be within specifications.No returned sample was received from the customer.No other quality issues were revealed during the review of the said records.The device history record for the zoom ap lamp, zm2550, serial # (b)(4) is not available for review since the lamp was manufactured in 2006 and the record retention for the dhr is five years.Based on the results of the investigation and the info provided, it appears that the incident happened due to the pt's movement during the procedure potentially exposing the pt's inside of the mouth and lips to the whitening gel.

• Brand Name: ZOOM AP LAMP
• Type of Device: ZOOM AP LAMP
• Manufacturer (Section D): DISCUS DENTAL, LLC; ontario CA 91761
• Manufacturer Contact: carmelita torres ; 1700 a south baker ave.; ontario, CA 91761 ; 9095703512
• MDR Report Key: 3927393
• MDR Text Key: 19804859
• Report Number: 1000582314-2014-00012
• Device Sequence Number: 1
• Product Code: EEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZOOM AP 2.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other