FDA Adverse Event
Injury
Summary report: N
EXPA-SYL
MDR report key: 1394361
·
Received May 28, 2009
Report
- Report Number
- 1815757-2009-00001
- Event Type
- Injury
- Date Received
- May 28, 2009
- Date of Event
- April 23, 2009
- Report Date
- April 30, 2009
- Manufacturer
- PRODUITS DENTAIRES PIERRE ROLLAND
- Product Code
- MVL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
ON (B) (6) 2009, THE PATIENT REPORTED THAT HE WENT TO HIS DENTIST ON (B) (6) FOR A ROUTINE CROWN SEATING AND THAT AFTER HIS DENTIST APPLIED EXPA-SYL, HE IMMEDIATELY EXPERIENCED AN ALLERGIC REACTION WITH BURNING AND SHORTNESS OF BREATH. AN AMBULANCE WAS CALLED AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM FOR TREATMENT WITH IV, BENADRYL AND EPINEPHRINE. THE REACTION GRADUALLY RESOLVED AND AFTER TWO HOURS THE PATIENT WAS DISCHARGED AND BY THAT AFTERNOON THE PATIENT REPORTED THAT HE FELT FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPA-SYL | CORD, RETRACTION | MVL | PRODUITS DENTAIRES PIERRE ROLLAND | 1599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other| R |