FIXODENT CONTROL
Received Feb 2, 2005 · Event occurred Oct 18, 2004
Report MW4003864 · MDR key 570519
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
63 YR
- Hives
- Heart rate, increased
- Hospitalization required
Narrative
Description of Event or Problem
PT NEVER USED ANY PRODUCT BEFORE ON THEIR DENTURES. UPON VISITING DENTIST FOR A ROUTINE CHECKUP DENTIST PROVIDED THEM WITH A TUBE (NO CHARGE) OF FIXODENT CONTROL DENTURE ADHESIVE CREAM. PT DID NOT USE THIS PRODUCT UNTIL 4 DAYS LATER AT ABOUT 12 NOON. PT AWOKE AT ABOUT 4 AM THE NEXT DAY, WITH A FEELING THAT THEIR HEART "WAS RACING" AND HAD HIVES ON ARMS. THEY CALLED 911, AND WERE TAKEN TO HOSPITAL, WHERE THEY WERE RELEASED 4 OR 5 HOURS LATER. PT HAS NOT RETURNED TO USING THIS PRODUCT; AND HAS NO NEW ADVERSE EVENTS TO REPORT.