FDA Adverse Event
Other
Summary report: N
GLUMA DESENSITIZER
MDR report key: 2163487
·
Received June 2, 2011
Report
- Report Number
- 9610902-2011-00013
- Event Type
- Other
- Date Received
- June 2, 2011
- Date of Event
- October 3, 2007
- Report Date
- June 2, 2011
- Manufacturer
- HERAEUS KULZER, GMBH
- Product Code
- KLE
- PMA / PMN Number
- K962812
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED AS A RESULT OF CORRECTIVE MEASURE TO FDA FINDING.
Description of Event or Problem · 1
THE PT WAS TREATED WITH GLUMA DESENSITIZER ON EXPOSED DENTINE TO PREVENT HYPER-SENSITIVITY. NO ADD'L MATERIALS WERE USED. THE PT HAS EARLIER SHOWN ALLERGIC REACTIONS WHEN TREATED WITH COMPOSITE. RUBBER DAM HAS NOT BEEN USED. THE PT SHOWED AN ALLERGIC REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLUMA DESENSITIZER | KLE TOOTH RESIN BONDING AGENT | KLE | HERAEUS KULZER, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |