| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER | PH BUFFER | VALEANT PHARMACEUTICALS INTERNATIONAL | JCC | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-06 | 0 | 1. R |
Patient 1
THE PRODUCT IS NOT AVAILABLE FOR RETURN AND THE LOT NUMBER WAS NOT REPORTED. AN ASSESSMENT OF THE EVENT WAS COMPLETED BY VALEANT MEDICAL PERSONNEL. THE DENTIST USED CARBOCAINE AND SEPTOCAINE, WHICH ARE NOT PART OF OUR RECOMMENDED LOCAL ANESTHETICS. IT IS POSSIBLE THAT SORENESS IS A RESULT OF HYPERTONICITY IN THE TISSUE, WHICH DID RESOLVE. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.
Patient 1
A DENTIST REPORTED THAT A FEW DAYS AFTER DENTAL TREATMENT A PATIENT HAD TRISMUS AND WAS UNABLE TO OPEN HIS JAW. PATIENT ALSO HAD PAIN AND SORENESS. DURING TREATMENT THE DENTIST ADMINISTERED 2 CARTRIDGES OF CARBOCAINE AND 2 CARTRIDGES OF SEPTOCAINE FOR UPPER AND LOWER FILLING ON THE RIGHT SIDE. THE PATIENT WAS INSTRUCTED TO USE WARM MOIST HEAT (COMPRESSES) AND TAKE ADVIL. A FOLLOW-UP VISIT A WEEK LATER, THE DENTIST MADE AN IN OFFICE NIGHT BITE TO OPEN THE PATIENT'S MOUTH. THE PATIENT IS FEELING BETTER AND IS BELIEVED TO BE RECOVERED.
Patient 1
THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER WAS NOT REPORTED. THE MANUFACTURER'S INVESTIGATION IDENTIFIED NO CAUSAL FACTORS AND NO CONCLUSION CAN BE DRAWN.