FDA Adverse Event
Injury
Summary report: N
SURGICAL HANDPIECE 3555
MDR report key: 1163557
·
Received September 17, 2008
Report
- Report Number
- 8010493-2008-00017
- Event Type
- Injury
- Date Received
- September 17, 2008
- Date of Event
- August 15, 2008
- Report Date
- August 20, 2008
- Manufacturer
- KALTENBACH & VOIGT GMBH
- Product Code
- EKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT WAS PRESCRIBED HYDROCODONE AND GIVEN ANTIBIOTICS PRIOR TO SURGERY FOR TOOTH EXTRACTION. NEOSPORIN WAS GIVEN FOR THE BURN AND THE PATIENT WAS INSTRUCTED TO CONTINUE THE HYDROCODONE IF THE BURN ON THE PATIENT'S LIP WAS PAINFUL. THE DOCTOR'S OFFICE STATED THAT THE PATIENT WAS DOING FINE. THE OFFICE STAFF WAS NOT FOLLOWING PROPER PROCEDURE FOR MAINTENANCE. PROPER MAINTENANCE WAS DISCUSSED. THE SPRAY ATTACHMENT WAS BROKEN, BEARINGS WERE WORN AND GRITTY, AND FALLING APART. HIGH DEBRIS LEVEL WAS PRESENT.
Description of Event or Problem · 1
THE HANDPIECE BURNED THE PATIENT'S LIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGICAL HANDPIECE 3555 | DENTAL HANDPIECE AND ACCESSORIES | EKK | KALTENBACH & VOIGT GMBH | 3555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |