InjuryEBH
JELTRATE
Received Apr 22, 2005 · Event occurred Mar 24, 2005
Report 2515379-2005-00106 · MDR key 594916
Device
Generic name
Alginate Impression Material
Manufacturer
Dentsply CaulkModel number
NACatalog number
609522
Lot number
0412C73
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Blister(s)
- Swelling
- Treatment with medication(s)
Narrative
Description of Event or Problem
A DOCTOR REPORTED THAT A PATIENT WITH KNOWN ALLERGIES TO SEVERAL SUBSTANCES EXPERIENCED BLISTERING IN THE MOUTH, SWELLING OF THE TONGUE, AND A STICKING FEELING IN THE MOUTH AFTER UPPER AND LOWER IMPRESSIONS WERE TAKEN USING JELTRATE. THE PATIENT TOOK BENADRYL T RELIEVE THE SYMPTOMS, THOUGH NO FURTHER INTERVENTION WAS SOUGHT OR ADMINISTERED.