GC FUJICEM 2 AUTOMIX
Received Nov 5, 2014 · Event occurred Oct 10, 2014
Report 1410097-2014-00004 · MDR key 4251829
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Dyspnea
- Hypersensitivity/Allergic reaction
- Respiratory Distress
Narrative
Additional Manufacturer Narrative
DENTIST WAS CONCERNED THAT POSSIBLY THE SILICONE DIOXIDE IN THE PRODUCT CEMENT MAY BE THE CAUSE, DR (B)(4) FROM GC AMERICA SPOKE WITH DR (B)(6). AN OPEN FORMULA AND SDS WAS SENT TO DR (B)(6) FOR HIM TO FORWARD TO PT'S PHYSICIAN. DR (B)(4) REVIEWED PROPRIETARY FORMULA AND NOTED NO SULFITES ARE IN THE PRODUCT. PRODUCT DOES CONTAIN SODIUM BENZENSULFINATE DIHYDRIDE, WHICH IS A PRESERVATIVE,
Description of Event or Problem
ON (B)(6) 2014, DR (B)(6) HAD A PT THAT HE PLACED A UNIT 3 PFM BRIDGE USING GC FUJICEM 2. PT COMPLAINED OF SOME BREATHING PROBLEMS TO THE DENTAL STAFF. DENTIST FOLLOWED UP BY PHONE THE NEXT DAY AND WAS TOLD SHE WAS DOING BETTER BUT BY FRIDAY MORNING, (B)(6), SHE HAD DEVELOPED SEVERE BREATHING PROBLEMS AND WAS HOSPITALIZED.