FDA Adverse Event
Other
Summary report: N
GLUMA DESENSITIZER
MDR report key: 2238469
·
Received August 12, 2011
Report
- Report Number
- 9610902-2011-00015
- Event Type
- Other
- Date Received
- August 12, 2011
- Date of Event
- May 19, 2011
- Report Date
- August 12, 2011
- Manufacturer
- HERAEUS KULZER GMBH
- Product Code
- KLE
- PMA / PMN Number
- K962812
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
DENTAL PT WAS HAVING A CROWN PREP DONE AND THE DENTIST WAS NOT ABLE TO NUMB THE AREA SUCCESSFULLY WITH THE LOCAL ANESTHETIC, SEPTOCAINE. GLUMA DESENSITIZER LIQUID WAS THEN USED. AFTER THE GLUMA APPLICATION, THE PT EXPERIENCED SEVERE PAIN FOR A PERIOD OF 2-3 MINUTES BUT THEN APPEARED TO BE FINE. IT WAS DISCOVERED THAT THE REQUIRED RUBBER DAM WAS NOT USED WHEN APPLYING THE GLUMA DESENSITIZER. THE PT HAS SINCE RETURNED TO THE DENTIST TO COMPLETE THE CROWN AND HE REPORTED NO FURTHER SYMPTOMS. THE PT DID NOT SEEK MED ASSISTANCE FROM A PHYSICIAN.
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 | 60 YR | Other |