CALIBRA UNIV CEM SYR REF TRAN
Received Feb 28, 2022
Report 2515379-2022-00040 · MDR key 13623055
Device
Product problems
- Patient-Device Incompatibility
- Output Problem
- Unexpected Color
- Patient-Device Incompatibility
- Unexpected Color
Patient
Unknown
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE. REQUEST FOR ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES AVAILABLE.
Description of Event or Problem
IN THIS EVENT IT HAS BEEN REPORTED THAT CALIBRA UNIVERSAL CEM SYRINGE CONTENTS IS YELLOW AND CAUSING SENSITIVITY. INJURY IS UNKNOWN AT THE TIME OF THIS MDR, ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.
Description of Event or Problem
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PATIENT OUTCOME.