FDA Adverse Event
Injury
Summary report: N
DU 900
MDR report key: 7845114
·
Received September 5, 2018
Report
- Report Number
- 9681479-2018-00005
- Event Type
- Injury
- Date Received
- September 5, 2018
- Date of Event
- August 16, 2018
- Report Date
- August 28, 2018
- Manufacturer
- W&H DENTALWERK BUERMOOS GMBH
- Product Code
- EBW
- PMA / PMN Number
- K060287
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AFTER ANALYSING THE PRODUCT, THERE WAS NO PROBLEM FOUND. THE ANALYSIS SHOWED IT WAS NORMAL WEAR AND TEAR.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ERROR OCCURED DURING THE PROCEDURE WITH THE DRILL. ANOTHER TOOL COULD NOT BE USED AND THE PATIENT THAT TO COME BACK TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 685840 | DU 900 | DENTAL DRILL UNIT | EBW | W&H DENTALWERK BUERMOOS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |