FDA Adverse Event
Other
Summary report: N
ZOOM WHITENING LAMP AND PROCEDURE KIT
MDR report key: 2508511
·
Received July 21, 2011
Report
- Report Number
- 2032714-2011-00006
- Event Type
- Other
- Date Received
- July 21, 2011
- Date of Event
- June 16, 2011
- Report Date
- July 11, 2001
- Manufacturer
- DISCUS DENTAL, LLC
- Product Code
- EEG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
REVIEWED THE DHR FOR THE ZOOM WHITENING SYSTEM. THE LAMP USED IN THE PROCEDURE WAS WITHIN THE MANUFACTURING SPECIFICATIONS UPON SHIPMENT TO THE CUSTOMER. THE RETAIN SAMPLE OF THE CHAIR SIDE GEL USED IN THE PROCEDURE (AND GOES DIRECTLY ON THE TEETH) WAS WITHIN ALL MANUFACTURING SPECIFICATIONS.
Description of Event or Problem · 1
DURING THE SECOND (OUT OF 3) ZOOM CHAIR SIDE WHITENING CYCLES THE DENTIST HAD TO STOP BECAUSE THE PATIENT HAD TOOTH SENSITIVITY. THE PATIENT WAS PRESCRIBED 800MG IBUPROFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZOOM WHITENING LAMP AND PROCEDURE KIT | EEG | DISCUS DENTAL, LLC | ZM2564 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 MO | Other | 800MG IBUPROFEN |