3M UNITEK TRANSBOND TX ADHESIVE
Received Jun 13, 2017 · Event occurred May 19, 2017
Report 2020467-2017-00002 · MDR key 6639138
Device
Generic name
Adhesive, Bracket And Tooth Conditioner, Resin
Manufacturer
3m Unitek CorporaionCatalog number
712-030
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
17 YR
- Eye Injury
- Eye Injury
Narrative
Description of Event or Problem
ON (B)(6) 2017, 3M WAS NOTIFIED THAT A (B)(6) YEAR-OLD FEMALE WAS DIAGNOSED WITH A CORNEAL ABRASION, AFTER PARTICLES OF CURED 3M UNITEK TRANSBOND XT ADHESIVE ALLEGEDLY GOT INTO HER EYE DURING A POLISHING PROCEDURE AFTER ORTHODONTIC BRACKETS WERE REMOVED. THE PATIENT EXPERIENCED PAIN, BLURRED VISION AND A HEADACHE AS A RESULT. THE EYE WAS FLUSHED BY THE ORTHODONTIC OFFICE IN THE EMPLOYEE EYE WASH, AND THE PATIENT SAW AN OPHTHALMOLOGIST LATER THE SAME DAY. THE OPHTHALMOLOGIST OBSERVED PARTICLES IN THE PATIENTS EYE AND RINSED THE EYE TO REMOVE THE PARTICLES. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC EYE DROP TO USE FOR 10 DAYS.