FDA Adverse Event
Injury
Summary report: N
CAVITRON JET-FRESH, MINT
MDR report key: 476106
·
Received August 7, 2003
Report
- Report Number
- 2424472-2003-00097
- Event Type
- Injury
- Date Received
- August 7, 2003
- Report Date
- July 9, 2003
- Manufacturer
- DENTSPLY PROFESSIONAL
- Product Code
- EJR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
THE DOCTOR REPORTED THAT FOUR STAFF MEMBERS AND ONE PT HAD AN ALLERGIC REACTION TO JET FRESH. ONE STAFF MEMBER REQUIRED A SHOT OF BENEDRYL FOR TREATMENT OF HIVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAVITRON JET-FRESH, MINT | CLEANING POWDER | EJR | DENTSPLY PROFESSIONAL | NA | 030117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |