FDA Adverse Event
Injury
Summary report: N
VENUS DIAMOND SYRINGE REFILL 1X4G A1
MDR report key: 3922272
·
Received July 9, 2014
Report
- Report Number
- 9610902-2014-00040
- Event Type
- Injury
- Date Received
- July 9, 2014
- Report Date
- June 12, 2014
- Manufacturer
- HERAEUS KULZER GMBH
- Product Code
- EBF
- PMA / PMN Number
- K073554
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. METHOD/RESULTS/CONCLUSION; DEVICE HAS NOT BEEN RETURNED BY CUSTOMER.
Description of Event or Problem · 1
(B)(6) REPORTS ALLEGED GUM TISSUE REACTION TO VENUS DIAMOND. THIS OCCURRED IN (B)(6). NO OTHER DETAILS WERE PROVIDED. THE MALFUNCTION WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400668 | VENUS DIAMOND SYRINGE REFILL 1X4G A1 | MATERIAL, TOOTH SHADE, RESIN | EBF | HERAEUS KULZER GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |