KALSOGEN PLUS

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. PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO KALSOGEN PLUS DENTAL CEMENT. THE SYMPTOMS REPORTED INCLUDED BOWEL IRRITATIONS AND HEAD ITCHING. AFTER REMOVING THE MATERIAL, THE PATIENT IS "GETTING BETTER."

Additional Manufacturer Narrative

BOTH THE RETURNED PRODUCT AND RETAIN PRODUCT HAVE BEEN EVALUATED. THE RETAIN SAMPLE MEETS SPECIFICATION. THE LIQUID OF THE RETURNED SAMPLE HAS BECOME BROWN AND THE BOTTLE WAS NEARLY EMPTY. THE POWDER IS HUMID. IT APPEARS THE RETURNED SAMPLE WAS NOT STORED ACCORDING TO INSTRUCTIONS.