FDA Adverse Event
Other
Summary report: N
HALL SURGICAL BUR GUARD
MDR report key: 862173
·
Received June 5, 2007
Report
- Report Number
- 1017294-2007-00383
- 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: THE CUSTOMER RETURNED SEVERAL BUR GUARDS FOR EVALUATION SINCE THE ONE ASSOCIATED WITH A BURN TO THE PT'S LIP COULD NOT BE IDENTIFIED. AN EVALUATION OF THIS BUR GUARD WAS FOUND BEARING DAMAGE. IN ADDITION, RUST-LIKE DEPOSITS WERE NOTED IN THE ASSEMBLY INDICATING POSSIBLE IMMERSION. THE CUSTOMER HAS BEEN PROVIDED ADD'L EDUCATION ON THE USE AND CARE OF THIS PRODUCT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING USE OF A BUR GUARD IN ORAL SURGERY, THE PT RECEIVED A BUR 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 | HALL SURGICAL BUR GUARD | BUR GUARD | DZI | CONMED LINVATEC | NA | NOV06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R | MICROPOWER ORAL MAX HS DRILL| CAT #: 00602002500 & SERIAL: UNKNOWN |