IPS CONTRAST SPRAY CHAIRSIDE 50ML
Received Nov 28, 2011 · Event occurred Oct 20, 2011
Report 9612352-2011-00008 · MDR key 2394900
Device
Generic name
Accessory To Optical Impression System
Manufacturer
Ivoclar Vivadent AgModel number
614435ANLot number
ML8503
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Asthma
Narrative
Description of Event or Problem
PATIENT CLAIMS SHE EXPERIENCED A MAJOR ASTHMATIC ATTACK AFTER TREATMENT WITH CONTRAST SPRAY CHAIRSIDE AND REQUIRED A TRIP TO THE HOSPITAL.
Additional Manufacturer Narrative
COMPLAINT WAS INVESTIGATED AND CLINICIAN INDICATED THAT THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS WHEN SHE LEFT THE OFFICE AND APPEARED TO BE FINE. SHE NEVER REPORTED THAT SHE HAD ASTHMA DURING HER MEDICAL EXAM. PATIENT WAS HEAVY SET THAT ALSO MIGHT CAUSE DIFFICULTIES BREATHING. PATIENT IS REPORTED TO HAVE FULLY RECOVERED. THE PRODUCT MSDS INCLUDES INFORMATION REGARDING THE CONTENTS AS WELL AS RESPIRATORY PRECAUTIONS.