inforMED
InjuryEBF

SDI SUPER ETCHJ JUMBO 37%

Received Sep 8, 2023

Report MW5145457 · MDR key 17720070

Device

Generic name

Material, Tooth Shade, Resin

Manufacturer

Sdi Limited

Lot number

220601

Patient

Unknown

  • Burning Sensation
  • Burning Sensation

Narrative

Description of Event or Problem

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.