FDA Adverse Event
Other
Summary report: N
MICROPOWER ORAL MAX HS DRILL, DL
MDR report key: 862172
·
Received June 5, 2007
Report
- Report Number
- 1017294-2007-00375
- Event Type
- Other
- Date Received
- June 5, 2007
- Date of Event
- April 13, 2007
- Report Date
- May 15, 2007
- Manufacturer
- CONMED LINVATEC
- Product Code
- DZI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FINDINGS: AN EVALUATION COULD NOT BE PERFORMED AS THE DRILL IN USE COULD NOT BE IDENTIFIED BY THE USER AND THEREFORE, WAS NOT RETURNED. THE CUSTOMER HAS BEEN PROVIDED ADDITIONAL EDUCATION ON THE USE AND CARE OF THIS PRODUCT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING USE OF THIS DRILL IN ORAL SURGERY, THE PT RECEIVED A BURN TO THE LIP. THE AFFECTED AREA WAS TREATED WITH ANTIBIOTIC OINTMENT AND REPORTED TO BE HEALING WELL WITHOUT FURTHER TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROPOWER ORAL MAX HS DRILL, DL | HIGH SPEED DRILL | DZI | CONMED LINVATEC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R | CAT#: 00137501200 & LOT#: NOV06| HALL SURGICAL BUR GUARD |