IN PREPARATION FOR ORTHODONTIC TREATMENT. A STOMATOLOGIST INJECTED A DENTAL ANESTHETIC INTRAORALLY INTO A PATIENT BEFORE MAKING AN INCISION IN THE GUM IN ORDER TO EXPOSE AN UNDERGUM CUSPID TOOTH. APPROXIMATELY FIVE MINUTES FOLLOWING THE ORAL SURGERY, THE ORTHODONTIST APPLIED ORTHODONTIC ETCHING GEL, ORTHODONTIC PRIMER, AND ORTHODONTIC ADHESIVE WITH ATTACHMENT TO THE PATIENT'S TOOTH. THE FIRST PREPARATION OF THE TOOTH WAS NOT ADEQUATE, SO THE ORTHODONTIST RE-PREPARED THE TOOTH. THE TREATMENT WAS INITIALLY UNEVENTFUL; HOWEVER, THE PATIENT STARTED TO EXPRESS DISTRESS AND SHORTLY THEREAFTER CARDIAC ARREST OCCURRED. SUBSEQUENT ATTEMPTS TO REVIVE THE PATIENT WERE UNSUCCESSFUL.
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Patient 1
IT IS NOT CLEAR WHAT ORTHODONTIC DEVICES WERE USED IN THIS EVENT, SINCE THE ORTHODONTIST HAS NOT PROVIDED THIS INFORMATION TO 3M. HOWEVER, 3M UNITEK HAS DETERMINED THAT THE FOLLOWING DEVICES WERE SHIPPED TO THE ORTHODONTIST IN 2006 AND 2007. TRANSBOND XT PRIMER, LOT #S 5CJ, 6CX, 6EB; TRANSBOND XT ETCHING GEL, LOT # 6HE; TRANSBOND PLUS SELF ETCHING PRIMER, LOT # 266707; TRANSBOND XT ADHESIVE IN CAPSULES, LOT #S PH, RK, WN.