MAUDE Adverse Event Report: SDI LIMITED SDI SUPER ETCHJ JUMBO 37%; MATERIAL, TOOTH SHADE, RESIN

Lot Number 220601

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Event Description

Reseller, darby dental supply llc received report from dr (b)(6), phone (b)(6) that product super etch (jumbo) was used on patient, (b)(6).Patient complained of burning sensation in the cheeks and tooth.Sdi inc.Contacted the surgery place on (b)(6) for more details and was informed that the patient was an assistant working at this surgery place.Office declined to provide more details due to confidentiality and suggested to call again to speak to office manager.Sdi spoke to the office again the next day and was told it was against their policy to disclose patient's information.

• Brand Name: SDI SUPER ETCHJ JUMBO 37%
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): SDI LIMITED; victoria ; AS
• MDR Report Key: 17720070
• MDR Text Key: 323167195
• Report Number: MW5145457
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2023

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
• Device Lot Number: 220601
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2023
• Patient Sequence Number: 1