FDA Adverse Event
Injury
Summary report: N
SURGICAL HANDPIECE 3555 NLA
MDR report key: 1736853
·
Received June 24, 2010
Report
- Report Number
- 1017522-2010-00011
- Event Type
- Injury
- Date Received
- June 24, 2010
- Date of Event
- May 14, 2010
- Report Date
- May 26, 2010
- Manufacturer
- KAVO DENTAL GMBH
- Product Code
- EKX
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
A DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PT USING A DENTAL ELECTRIC HANDPIECE WHEN THE PTS INSIDE LOWER LIP WAS BURNED BY THE HEAD OF THE HANDPIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGICAL HANDPIECE 3555 NLA | DENTAL HANDPIECE | EKX | KAVO DENTAL GMBH | 3555 NLA | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |